Label: PREDNISONE tablet

  • NDC Code(s): 70954-057-10, 70954-058-10, 70954-058-20, 70954-058-30, view more
    70954-058-40, 70954-059-10, 70954-059-20, 70954-059-30, 70954-059-40, 70954-060-10, 70954-060-20, 70954-060-30, 70954-061-10
  • Packager: Novitium Pharma LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 1, 2020

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

  • DESCRIPTION

    Prednisone Tablets, USP are available for oral administration containing 2.5 mg, 5 mg, 10 mg, 20 mg and 50 mg of prednisone, USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and sodium starch glycolate.

    Prednisone Tablets, USP contain prednisone 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 pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy-. The structural formula is represented below:


    Prednisone structure

    Molecular Formula: C21H26O5

    Molecular Weight: 358.44

    Prednisone is a white or almost white crystalline powder. It is slightly soluble in acetone, ethanol, ethylacetate and methanol.


  • 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 & USAGE


    Prednisone Tablets, USP 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


    WARNINGS
    General

    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 childbearing 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 PATIENTS


    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

    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 & ADMINISTRATION


    The initial dosage of prednisone may vary from 5 mg to 60 mg 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 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 are available in the following strengths and package sizes:


    Prednisone Tablets, USP 2.5 mg for oral administration are supplied as follows:

    White to off white, round tablet, debossed with “057” on one side and bisect on the other side.


    NDC 70954-057-10 Bottles of 100 Tablets with child resistant caps


    Prednisone Tablets, USP 5 mg for oral administration are supplied as follows:

    White to off white, round tablet, debossed with “058” on one side and bisect on the other side.


    NDC 70954-058-10 Bottles of 100 Tablets with child resistant caps

    NDC 70954-058-20 Bottles of 1000 Tablets with child resistant caps

    NDC 70954-058-30 Blister Packs (Unit-of-Use 21 Tablets)

    NDC 70954-058-40 Blister Packs (Unit-of-Use 48 Tablets)


    Prednisone tablets, USP 10 mg for oral administration are supplied as follows:

    White to off white, round tablet, debossed with “059” on one side and bisect on the other side.


    NDC 70954-059-10 Bottles of 100 Tablets with child resistant caps

    NDC 70954-059-20 Bottles of 1000 Tablets with child resistant caps

    NDC 70954-059-30 Blister Packs (Unit-of-Use 21 Tablets)

    NDC 70954-059-40 Blister Packs (Unit-of-Use 48 Tablets)


    Prednisone tablets, USP 20 mg for oral administration are supplied as follows:

    White to off white, round tablet, debossed with “060” on one side and bisect on the other side.


    NDC 70954-060-10 Bottles of 100 Tablets with child resistant caps

    NDC 70954-060-20 Bottles of 500 Tablets with child resistant caps

    NDC 70954-060-30 Bottles of 1000 Tablets with child resistant caps


    Prednisone tablets, USP 50 mg for oral administration are supplied as follows:

    White to off white, round tablet, debossed with “061” on one side and bisect on the other side.


    NDC 70954-061-10 Bottles of 100 Tablets with child resistant cap.


    Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.]

    Protect from moisture.

    Dispense in a tight, light-resistant container as defined in the USP.


    Manufactured by:

    Novitium Pharma LLC

    70 Lake Drive, East Windsor

    New Jersey 08520

    Revised: 12/2019

    LB4212-01

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    PredniSONE Tablets, USP 2.5 mg

    PredniSONE Tablets, USP 2.5 mg 100 Counts
    label1

    PredniSONE Tablets, USP 5 mg

    PredniSONE Tablets, USP 5 mg 100 counts

    label2

    PredniSONE Tablets, USP 5 mg 1000 counts

    label3

    PredniSONE Tablets, USP 5 mg Blister Packs (Unit-of-Use 21 Tablets)
    blister1

    carton1

    PredniSONE Tablets, USP 5 mg Blister Packs (Unit-of-Use 48 Tablets)

    blister2

    carton2

    PredniSONE Tablets, USP 10 mg

    PredniSONE Tablets, USP 10 mg 100 counts

    label4

    PredniSONE Tablets, USP 10 mg 1000 counts

    label5

    PredniSONE Tablets, USP 10 mg Blister Packs (Unit-of-Use 21 Tablets)

    blister3

    carton3

    PredniSONE Tablets, USP 10 mg Blister Packs (Unit-of-Use 48 Tablets)

    blister4

    carton4

    PredniSONE Tablets, USP 20 mg

    PredniSONE Tablets, USP 20 mg 100 counts

    label6

    PredniSONE Tablets, USP 20 mg 500 counts

    label7

    PredniSONE Tablets, USP 20 mg 1000 counts

    label8

    PredniSONE Tablets, USP 50 mg

    PredniSONE Tablets, USP 50 mg 100 counts
    label9

  • INGREDIENTS AND APPEARANCE
    PREDNISONE 
    prednisone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70954-057
    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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize5mm
    FlavorImprint Code 057
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70954-057-10100 in 1 BOTTLE; Type 0: Not a Combination Product11/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21157511/15/2019
    PREDNISONE 
    prednisone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70954-058
    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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize6mm
    FlavorImprint Code 058
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70954-058-10100 in 1 BOTTLE; Type 0: Not a Combination Product11/15/2019
    2NDC:70954-058-201000 in 1 BOTTLE; Type 0: Not a Combination Product11/15/2019
    3NDC:70954-058-301 in 1 BOX11/15/2019
    321 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:70954-058-401 in 1 BOX11/15/2019
    448 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21157511/15/2019
    PREDNISONE 
    prednisone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70954-059
    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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize6mm
    FlavorImprint Code 059
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70954-059-10100 in 1 BOTTLE; Type 0: Not a Combination Product11/15/2019
    2NDC:70954-059-201000 in 1 BOTTLE; Type 0: Not a Combination Product11/15/2019
    3NDC:70954-059-301 in 1 BOX11/15/2019
    321 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:70954-059-401 in 1 BOX11/15/2019
    448 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21157511/15/2019
    PREDNISONE 
    prednisone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70954-060
    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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code 060
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70954-060-10100 in 1 BOTTLE; Type 0: Not a Combination Product11/15/2019
    2NDC:70954-060-20500 in 1 BOTTLE; Type 0: Not a Combination Product11/15/2019
    3NDC:70954-060-301000 in 1 BOTTLE; Type 0: Not a Combination Product11/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21157511/15/2019
    PREDNISONE 
    prednisone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70954-061
    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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code 061
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70954-061-10100 in 1 BOTTLE; Type 0: Not a Combination Product11/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21157511/15/2019
    Labeler - Novitium Pharma LLC (080301870)
    Establishment
    NameAddressID/FEIBusiness Operations
    Novitium Pharma LLC080301870MANUFACTURE(70954-057, 70954-058, 70954-059, 70954-060, 70954-061) , PACK(70954-057, 70954-058, 70954-059, 70954-060, 70954-061)