Label: PREDNISONE tablet

  • NDC Code(s): 59651-485-01, 59651-485-78, 59651-486-01, 59651-486-78, view more
    59651-486-99, 59651-487-01, 59651-487-05, 59651-487-78, 59651-488-01, 59651-488-05, 59651-488-78, 59651-489-01, 59651-489-78
  • Packager: Aurobindo Pharma Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 3, 2022

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake.

    Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below:
    Chemical Structure

    C21H26O5 M.W. 358.44

    Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol.

    FDA approved dissolution test specifications differ from USP.

  • CLINICAL PHARMACOLOGY

    Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.


    Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli.

  • INDICATIONS AND USAGE

    Prednisone tablets are indicated in the following conditions:


    Endocrine Disorders


    Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)


    Congenital adrenal hyperplasia


    Hypercalcemia associated with cancer


    Nonsuppurative thyroiditis

    Rheumatic Disorders


    As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:


    Psoriatic arthritis


    Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)


    Ankylosing spondylitis


    Acute and subacute bursitis


    Acute nonspecific tenosynovitis


    Acute gouty arthritis


    Post-traumatic osteoarthritis


    Synovitis of osteoarthritis


    Epicondylitis.


    Collagen Diseases


    During an exacerbation or as maintenance therapy in selected cases of:


    Systemic lupus erythematosus


    Systemic dermatomyositis (polymyositis)


    Acute rheumatic carditis


    Dermatologic Diseases


    Pemphigus


    Bullous dermatitis herpetiformis


    Severe erythema multiforme (Stevens-Johnson syndrome)


    Exfoliative dermatitis


    Mycosis fungoides


    Severe psoriasis


    Severe seborrheic dermatitis


    Allergic States


    Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional

    treatment:


    Seasonal or perennial allergic rhinitis


    Bronchial asthma


    Contact dermatitis


    Atopic dermatitis


    Serum sickness


    Drug hypersensitivity reactions

    Ophthalmic Diseases


    Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:


    Allergic corneal marginal ulcers


    Herpes zoster ophthalmicus


    Anterior segment inflammation


    Diffuse posterior uveitis and choroiditis

    Sympathetic ophthalmia


    Allergic conjunctivitis


    Keratitis


    Chorioretinitis


    Optic neuritis


    Iritis and iridocyclitis


    Respiratory Diseases


    Symptomatic sarcoidosis


    Loeffler’s syndrome not manageable by other means


    Berylliosis


    Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy


    Aspiration pneumonitis


    Hematologic Disorders


    Idiopathic thrombocytopenic purpura in adults


    Secondary thrombocytopenia in adults


    Acquired (autoimmune) hemolytic anemia


    Erythroblastopenia (RBC anemia)


    Congenital (erythroid) hypoplastic anemia


    Neoplastic Diseases


    For palliative management of:


    Leukemias and lymphomas in adults


    Acute leukemia of childhood

    Edematous States


    To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.


    Gastrointestinal Diseases


    To tide the patient over a critical period of the disease in:


    Ulcerative colitis


    Regional enteritis


    Nervous System


    Acute exacerbations of multiple sclerosis

    Miscellaneous


    Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy


    Trichinosis with neurologic or myocardial involvement

  • CONTRAINDICATIONS

    Prednisone tablets are contraindicated in systemic fungal infections and known hypersensitivity to components.

  • WARNINGS

    In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.


    Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used.


    Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.

    Usage in pregnancy


    Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of child-bearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy, should be carefully observed for signs of hypoadrenalism.


    Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.

    While on corticosteroid therapy patients should not be vaccinated against smallpox. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high dose, because of possible hazards of neurological complications and a lack of antibody response.


    The use of prednisone tablets in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate anti-tuberculous regimen.


    If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.


    Children who are on immunosuppressant drugs are more susceptible to infections than healthy children. Chickenpox and measles, for example, can have a more serious or even fatal course in children on immunosuppressant corticosteroids. In such children, or in adults who have not had these diseases, particular care should be taken to avoid exposure. If exposed, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobin (IVIG), as appropriate, may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.

  • PRECAUTIONS

    General Precautions

    Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.


    There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis.


    Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.


    The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction should be gradual.


    Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.


    Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.


    Steroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infection: diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer; renal insufficiency; hypertension; osteoporosis: and myasthenia gravis.


    Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.


    Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that corticosteroids affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect (See DOSAGE AND ADMINISTRATION).


    Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used.


    Convulsions have been reported with concurrent use of methylprednisolone and cyclosporine. Since concurrent use of these agents results in a mutual inhibition of metabolism, it is possible that adverse events associated with the individual use of either drug may be more apt to occur.

    Information for the Patient

    Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to obtain medical advice.

  • ADVERSE REACTIONS

    Fluid and Electrolyte Disturbances


    Sodium retention


    Fluid retention


    Congestive heart failure in susceptible patients


    Potassium loss


    Hypokalemic alkalosis


    Hypertension

    Musculoskeletal


    Muscle weakness


    Steroid myopathy


    Loss of muscle mass


    Osteoporosis


    Vertebral compression fractures


    Aseptic necrosis of femoral and humeral heads


    Pathologic fracture of long bones

    Gastrointestinal


    Peptic ulcer with possible perforation and hemorrhage


    Pancreatitis


    Abdominal distention


    Ulcerative esophagitis


    Dermatologic


    Impaired wound healing


    Thin fragile skin


    Petechiae and ecchymoses


    Facial erythema


    Increased sweating


    May suppress reactions to skin tests

    Metabolic


    Negative nitrogen balance due to protein catabolism

    Neurological


    Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment


    Convulsions


    Vertigo


    Headache

    Endocrine


    Menstrual irregularities


    Development of Cushingoid state


    Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness


    Suppression of growth in children


    Decreased carbohydrate tolerance


    Manifestations of latent diabetes mellitus


    Increased requirements for insulin or oral hypoglycemic agents in diabetics

    Ophthalmic


    Posterior subcapsular cataracts


    Increased intraocular pressure

    Glaucoma


    Exophthalmos

    Additional Reactions


    Urticaria and other allergic, anaphylactic or hypersensitivity reactions

  • DOSAGE AND ADMINISTRATION

    The initial dosage of prednisone may vary from 5 mg to 60 mg prednisone per day, depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, prednisone should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation, it may be necessary to increase the dosage of prednisone for a period of time consistent with the patient’s condition. If after long-term therapy the drug is to be stopped it is recommended that it be withdrawn gradually rather than abruptly.

    Multiple Sclerosis

    In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.)


    Alternate Day Therapy

    Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children.


    The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.


    A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight.


    The diurnal rhythm of the HPA axis is lost in Cushing’s disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects.


    During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy.


    The following should be kept in mind when considering alternate day therapy:


    1. Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids.
    2.  Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated.
    3.  In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable.
    4. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum.
    5. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone).
    6. The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am).
    7. In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed.
    8. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted.
    9. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.
  • HOW SUPPLIED

    Prednisone Tablets USP, 2.5 mg are yellow colored, round, biconvex tablets, scored on one side and “PE”, “11” on other side. They are supplied as follows:

    Bottles of 100                            NDC 59651-485-01
    10x10 Unit-dose Tablets           NDC 59651-485-78

    Prednisone Tablets USP, 5 mg are orange colored, round, biconvex tablets, scored on one side and “PI”, “5” on other side. They are supplied as follows:

    Bottles of 100                            NDC 59651-486-01
    Bottles of 1,000                         NDC 59651-486-99
    10x10 Unit-dose Tablets           NDC 59651-486-78

    Prednisone Tablets USP, 10 mg are white to off-white, round, biconvex tablets, scored on one side and “PI”, “10” on other side. They are supplied as follows:

    Bottles of 100                            NDC 59651-487-01
    Bottles of 500                            NDC 59651-487-05
    10x10 Unit-dose Tablets           NDC 59651-487-78

    Prednisone Tablets USP, 20 mg are white to off-white, round, biconvex tablets, scored on one side and “PI”, “20” on other side. They are supplied as follows:

    Bottles of 100                             NDC 59651-488-01
    Bottles of 500                             NDC 59651-488-05
    10x10 Unit-dose Tablets            NDC 59651-488-78

    Prednisone Tablets USP, 50 mg are white to off-white, round, biconvex tablets, scored on one side and “PI”, “50” on other side. They are supplied as follows:

    Bottles of 100                             NDC 59651-489-01
    10x10 Unit-dose Tablets            NDC 59651-489-78

    Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

    Dispense in a tight, child-resistant container as defined in the USP/NF.


    PROTECT FROM MOISTURE.

    Distributed by:
    Aurobindo Pharma USA, Inc.
    279 Princeton-Hightstown Road
    East Windsor, NJ 08520

    Manufactured by:
    Aurobindo Pharma Limited
    Hyderabad-500 032, India

    Issued: December 2021

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2.5 mg (100 Tablet Bottle)

    NDC 59651-485-01

    predniSONE
    Tablets, USP
    2.5 mg

    Rx only                100 Tablets
                
                AUROBINDO

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2.5 mg (100 Tablet Bottle)


  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2.5 mg 100 (10x10) Unit-dose Tablets

    NDC 59651-485-78

     predniSONE Tablets, USP
    2.5 mg

    Rx only

    100 (10x10) Unit-dose Tablets

    AUROBINDO

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2.5 mg 100(10x10) Unit-dose Tablets

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (100 Tablet Bottle)

    NDC 59651-486-01


    predniSONE
    Tablets, USP
    5 mg

    Rx only                100 Tablets

                  AUROBINDO

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (100 Tablet Bottle)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg 100 (10x10) Unit-dose Tablets

    NDC 59651-486-78

    predniSONE Tablets, USP
    5 mg

    Rx only

    100 (10x10) Unit-dose Tablets

    AUROBINDO
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg 100(10x10) Unit-dose Tablets


  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (100 Tablet Bottle)

    NDC 59651-487-01


    predniSONE
    Tablets, USP
    10  mg

    Rx only                100 Tablets

                AUROBINDO
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (100 Tablet Bottle)



  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg 100 (10x10) Unit-dose Tablets

    NDC 59651-487-78

    predniSONE Tablets, USP
    10 mg

    Rx only

    100 (10x10) Unit-dose Tablets

    AUROBINDO

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg 100(10x10) Unit-dose Tablets

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (100 Tablet Bottle)

    NDC 59651-488-01

    predniSONE
    Tablets, USP
    20 mg

    Rx only            100 Tablets

                 AUROBINDO

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (100 Tablet Bottle)


  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg 100 (10x10) Unit-dose Tablets

    NDC 59651-488-78

    predniSONE Tablets, USP
    20 mg

    Rx only

    100 (10x10) Unit-dose Tablets

    AUROBINDO
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (100 Tablets Carton)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 50 mg (100 Tablet Bottle)

    NDC 59651-489-01

    predniSONE
    Tablets, USP
    50 mg

    Rx only               100 Tablets

                 AUROBINDO



    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 50 mg (100 Tablet Bottle)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 50 mg 100 (10x10) Unit-dose Tablets

    NDC 59651-489-78

    predniSONE Tablets, USP
    50 mg

    Rx only

    100 (10x10) Unit-dose Tablets

    AUROBINDO
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 50 mg (100 Tablets Carton)

  • INGREDIENTS AND APPEARANCE
    PREDNISONE 
    prednisone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59651-485
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PREDNISONE (UNII: VB0R961HZT) (PREDNISONE - UNII:VB0R961HZT) PREDNISONE2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    Product Characteristics
    ColorYELLOWScore2 pieces
    ShapeROUND (Biconvex) Size7mm
    FlavorImprint Code PE;11
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59651-485-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/28/2022
    2NDC:59651-485-7810 in 1 CARTON03/28/2022
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21567203/28/2022
    PREDNISONE 
    prednisone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59651-486
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PREDNISONE (UNII: VB0R961HZT) (PREDNISONE - UNII:VB0R961HZT) PREDNISONE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorORANGEScore2 pieces
    ShapeROUND (Biconvex) Size7mm
    FlavorImprint Code PI;5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59651-486-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/28/2022
    2NDC:59651-486-991000 in 1 BOTTLE; Type 0: Not a Combination Product03/28/2022
    3NDC:59651-486-7810 in 1 CARTON03/28/2022
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21567203/28/2022
    PREDNISONE 
    prednisone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59651-487
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PREDNISONE (UNII: VB0R961HZT) (PREDNISONE - UNII:VB0R961HZT) PREDNISONE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (white to off-white) Score2 pieces
    ShapeROUND (Biconvex) Size7mm
    FlavorImprint Code PI;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59651-487-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/28/2022
    2NDC:59651-487-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/28/2022
    3NDC:59651-487-7810 in 1 CARTON03/28/2022
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21567203/28/2022
    PREDNISONE 
    prednisone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59651-488
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PREDNISONE (UNII: VB0R961HZT) (PREDNISONE - UNII:VB0R961HZT) PREDNISONE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (white to off-white) Score2 pieces
    ShapeROUND (Biconvex) Size9mm
    FlavorImprint Code PI;20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59651-488-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/28/2022
    2NDC:59651-488-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/28/2022
    3NDC:59651-488-7810 in 1 CARTON03/28/2022
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21567203/28/2022
    PREDNISONE 
    prednisone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59651-489
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PREDNISONE (UNII: VB0R961HZT) (PREDNISONE - UNII:VB0R961HZT) PREDNISONE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (white to off-white) Score2 pieces
    ShapeROUND (Biconvex) Size11mm
    FlavorImprint Code PI;50
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59651-489-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/28/2022
    2NDC:59651-489-7810 in 1 CARTON03/28/2022
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21567203/28/2022
    Labeler - Aurobindo Pharma Limited (650082092)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650918514ANALYSIS(59651-485, 59651-486, 59651-487, 59651-488, 59651-489) , MANUFACTURE(59651-485, 59651-486, 59651-487, 59651-488, 59651-489)