Label: IRBESARTAN - irbesartan tablet
view more33342-048-07, 33342-048-10, 33342-048-12, 33342-048-15, 33342-049-07, 33342-049-10, 33342-049-15, 33342-049-39
- Packager: Macleods Pharmaceuticals Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
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- BOXED WARNING(What is this?)
Irbesartan USP is an angiotensin II receptor (AT1 subtype) antagonist.
Irbesartan USP is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one.
Its molecular formula is C25H28N6O, and the structural formula:
Irbesartan USP is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan USP is slightly soluble in alcohol and methylene chloride and practically insoluble in water.
Irbesartan tablets USP is available for oral administration in unscored, film-coated tablets containing 75 mg, 150 mg, or 300 mg of irbesartan USP. Inactive ingredients include: carboxymethylcellulose calcium, colloidal silicon dioxide, magnesium stearate, povidone, sodium starch glycolate and talc. The film coating comprises of hypromellose, lactose monohydrate, polyethylene glycol and titanium dioxide.
- INDICATIONS & USAGE
Irbesartan USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Nephropathy in Type 2 Diabetic Patients
Irbesartan tablets USP is indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (>300 mg/day) in patients with type 2 diabetes and hypertension. In this population, irbesartan tablets USP reduce the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation) (see CLINICAL PHARMACOLOGY: Clinical Studies).
Pregnancy Category D
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue irbesartan tablets as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimesters of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus.
In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue irbesartan tablets, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to irbesartan for hypotension, oliguria, and hyperkalemia (see PRECAUTIONS: Pediatric Use).
When pregnant rats were treated with irbesartan from day 0 to day 20 of gestation (oral doses of 50 mg/kg/day, 180 mg/kg/day, and 650 mg/kg/day), increased incidences of renal pelvic cavitation, hydroureter and/or absence of renal papilla were observed in fetuses at doses ≥50 mg/kg/day (approximately equivalent to the maximum recommended human dose [MRHD], 300 mg/day, on a body surface area basis). Subcutaneous edema was observed in fetuses at doses ≥180 mg/kg/day (about 4 times the MRHD on a body surface area basis). As these anomalies were not observed in rats in which irbesartan exposure (oral doses of 50, 150, and 450 mg/kg/day) was limited to gestation days 6 to 15, they appear to reflect late gestational effects of the drug. In pregnant rabbits, oral doses of 30 mg irbesartan/kg/day were associated with maternal mortality and abortion. Surviving females receiving this dose (about 1.5 times the MRHD on a body surface area basis) had a slight increase in early resorptions and a corresponding decrease in live fetuses. Irbesartan was found to cross the placental barrier in rats and rabbits.
Radioactivity was present in the rat and rabbit fetus during late gestation and in rat milk following oral doses of radiolabeled irbesartan.
Hypotension in Volume- or Salt-Depleted Patients
Excessive reduction of blood pressure was rarely seen (<0.1%) in patients with uncomplicated hypertension. Initiation of antihypertensive therapy may cause symptomatic hypotension in patients with intravascular volume- or sodium-depletion, eg, in patients treated vigorously with diuretics or in patients on dialysis. Such volume depletion should be corrected prior to administration of irbesartan tablets, or a low starting dose should be used (see DOSAGE AND ADMINISTRATION).
If hypotension occurs, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.
Impaired Renal Function
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (eg, patients with severe congestive heart failure), treatment with angiotensin-converting-enzyme inhibitors has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Irbesartan tablets would be expected to behave similarly.
In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or BUN have been reported. There has been no known use of irbesartan tablets in patients with unilateral or bilateral renal artery stenosis, but a similar effect should be anticipated.
Information for Patients
Female patients of childbearing age should be told about the consequences of exposure to irbesartan during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.
Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of irbesartan or thiazide diuretics. Monitor lithium levels in patients receiving Avapro and lithium.
In vitro studies show significant inhibition of the formation of oxidized irbesartan metabolites with the known cytochrome CYP 2C9 substrates/inhibitors sulphenazole, tolbutamide and nifedipine. However, in clinical studies the consequences of concomitant irbesartan on the pharmacodynamics of warfarin were negligible. Based on in vitro data, no interaction would be expected with drugs whose metabolism is dependent upon cytochrome P450 isoenzymes 1A1, 1A2, 2A6, 2B6, 2D6, 2E1, or 3A4.
In separate studies of patients receiving maintenance doses of warfarin, hydrochlorothiazide, or digoxin, irbesartan administration for 7 days had no effect on the pharmacodynamics of warfarin (prothrombin time) or pharmacokinetics of digoxin. The pharmacokinetics of irbesartan were not affected by coadministration of nifedipine or hydrochlorothiazide.
Concomitant use of potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium.
Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)
In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including irbesartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving irbesartan and NSAID therapy.
The antihypertensive effect of angiotensin II receptor antagonists, including irbesartan, may be attenuated by NSAIDs including selective COX-2 inhibitors.
Dual Blockade of the Renin-Angiotensin System (RAS)
Dual blockade of the RAS with angiotensin-receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Closely monitor blood pressure, renal function, and electrolytes in patients on irbesartan tablets and other agents that affect the RAS.
In most patients no benefit has been associated with using two RAS inhibitors concomitantly. In general, avoid combined use of RAS inhibitors.
Do not coadminister aliskiren with irbesartan tablets in patients with diabetes. Avoid use of aliskiren with irbesartan tablets in patients with renal impairment (GFR <60 mL/min).
Carcinogenesis, Mutagenesis, Impairment of Fertility
No evidence of carcinogenicity was observed when irbesartan was administered at doses of up to 500/1000 mg/kg/day (males/females, respectively) in rats and 1000 mg/kg/day in mice for up to 2 years. For male and female rats, 500 mg/kg/day provided an average systemic exposure to irbesartan (AUC 0-24 hour, bound plus unbound) about 3 and 11 times, respectively, the average systemic exposure in humans receiving the maximum recommended dose (MRD) of 300 mg irbesartan/day, whereas 1000 mg/kg/day (administered to females only) provided an average systemic exposure about 21 times that reported for humans at the MRD. For male and female mice, 1000 mg/kg/day provided an exposure to irbesartan about 3 and 5 times, respectively, the human exposure at 300 mg/day.
Irbesartan was not mutagenic in a battery of in vitro tests (Ames microbial test, rat hepatocyte DNA repair test, V79 mammalian-cell forward gene-mutation assay). Irbesartan was negative in several tests for induction of chromosomal aberrations (in vitro-human lymphocyte assay; in vivo-mouse micronucleus study).
Irbesartan had no adverse effects on fertility or mating of male or female rats at oral doses ≤650 mg/kg/day, the highest dose providing a systemic exposure to irbesartan (AUC 0-24 hour, bound plus unbound) about 5 times that found in humans receiving the maximum recommended dose of 300 mg/day.
It is not known whether irbesartan is excreted in human milk, but irbesartan or some metabolite of irbesartan is secreted at low concentration in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Neonates with a history of in utero exposure to irbesartan:
If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function.
Irbesartan, in a study at a dose of up to 4.5 mg/kg/day, once daily, did not appear to lower blood pressure effectively in pediatric patients ages 6 to 16 years.
Irbesartan tablets have not been studied in pediatric patients less than 6 years old.
Of 4925 subjects receiving irbesartan in controlled clinical studies of hypertension, 911 (18.5%) were 65 years and over, while 150 (3.0%) were 75 years and over. No overall differences in effectiveness or safety were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. (See CLINICAL PHARMACOLOGY: Pharmacokinetics, Special Populations, and Clinical Studies.)
- ADVERSE REACTIONS
Irbesartan tablets have been evaluated for safety in more than 4300 patients with hypertension and about 5000 subjects overall. This experience includes 1303 patients treated for over 6 months and 407 patients for 1 year or more. Treatment with irbesartan tablets was well-tolerated, with an incidence of adverse events similar to placebo. These events generally were mild and transient with no relationship to the dose of irbesartan tablets.
In placebo-controlled clinical trials, discontinuation of therapy due to a clinical adverse event was required in 3.3% of patients treated with irbesartan tablets, versus 4.5% of patients given placebo.
In placebo-controlled clinical trials, the following adverse event experiences reported in at least 1% of patients treated with irbesartan tablets (n=1965) and at a higher incidence versus placebo (n=641), excluding those too general to be informative and those not reasonably associated with the use of drug because they were associated with the condition being treated or are very common in the treated population, include: diarrhea (3% vs 2%), dyspepsia/heartburn (2% vs 1%), and fatigue (4% vs 3%).
The following adverse events occurred at an incidence of 1% or greater in patients treated with irbesartan, but were at least as frequent or more frequent in patients receiving placebo: abdominal pain, anxiety/nervousness, chest pain, dizziness, edema, headache, influenza, musculoskeletal pain, pharyngitis, nausea/vomiting, rash, rhinitis, sinus abnormality, tachycardia and urinary tract infection.
Irbesartan use was not associated with an increased incidence of dry cough, as is typically associated with ACE inhibitor use. In placebo-controlled studies, the incidence of cough in irbesartan-treated patients was 2.8% versus 2.7% in patients receiving placebo.
The incidence of hypotension or orthostatic hypotension was low in irbesartan-treated patients (0.4%), unrelated to dosage, and similar to the incidence among placebo-treated patients (0.2%). Dizziness, syncope, and vertigo were reported with equal or less frequency in patients receiving irbesartan compared with placebo.
In addition, the following potentially important events occurred in less than 1% of the 1965 patients and at least 5 patients (0.3%) receiving irbesartan in clinical studies, and those less frequent, clinically significant events (listed by body system). It cannot be determined whether these events were causally related to irbesartan:
Body as a Whole: fever, chills, facial edema, upper extremity edema
Cardiovascular: flushing, hypertension, cardiac murmur, myocardial infarction, angina pectoris, arrhythmic/conduction disorder, cardio-respiratory arrest, heart failure, hypertensive crisis
Dermatologic: pruritus, dermatitis, ecchymosis, erythema face, urticaria
Endocrine/Metabolic/Electrolyte Imbalances: sexual dysfunction, libido change, gout
Gastrointestinal: constipation, oral lesion, gastroenteritis, flatulence, abdominal distention
Musculoskeletal/Connective Tissue: extremity swelling, muscle cramp, arthritis, muscle ache, musculoskeletal chest pain, joint stiffness, bursitis, muscle weakness
Nervous System: sleep disturbance, numbness, somnolence, emotional disturbance, depression, paresthesia, tremor, transient ischemic attack, cerebrovascular accident
Renal/Genitourinary: abnormal urination, prostate disorder
Respiratory: epistaxis, tracheobronchitis, congestion, pulmonary congestion, dyspnea, wheezing
Special Senses: vision disturbance, hearing abnormality, ear infection, ear pain, conjunctivitis, other eye disturbance, eyelid abnormality, ear abnormality
Nephropathy in Type 2 Diabetic Patients
In clinical studies in patients with hypertension and type 2 diabetic renal disease, the adverse drug experiences were similar to those seen in patients with hypertension with the exception of an increased incidence of orthostatic symptoms (dizziness, orthostatic dizziness, and orthostatic hypotension) observed in IDNT (proteinuria ≥900 mg/day, and serum creatinine ranging from 1.0-3.0 mg/dL). In this trial, orthostatic symptoms occurred more frequently in the irbesartan tablets group (dizziness 10.2%, orthostatic dizziness 5.4%, orthostatic hypotension 5.4%) than in the placebo group (dizziness 6.0%, orthostatic dizziness 2.7%, orthostatic hypotension 3.2%).
The following adverse reactions have been identified during post-approval use of irbesartan tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or to establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to irbesartan tablets.
The following have been reported: urticaria; angioedema (involving swelling of the face,lips, pharynx, and/or tongue); increased liver function tests; jaundice; hepatitis;hyperkalemia, and thrombocytopenia.
Impaired renal function, including cases of renal failure, has been reported.
Cases of increased CPK and rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.
Laboratory Test Findings
In controlled clinical trials, clinically important differences in laboratory tests were rarely associated with administration of irbesartan tablets.
Creatinine, Blood Urea Nitrogen: Minor increases in blood urea nitrogen (BUN) or serum creatinine were observed in less than 0.7% of patients with essential hypertension treated with irbesatan tablets alone versus 0.9% on placebo. (See PRECAUTIONS: Impaired Renal Function.)
Hematologic: Mean decreases in hemoglobin of 0.2 g/dL were observed in 0.2% of patients receiving irbesartan tablets compared to 0.3% of placebo-treated patients. Neutropenia (<1000 cells/mm3) occurred at similar frequencies among patients receiving irbesartan tablets (0.3%) and placebo-treated patients (0.5%).
Nephropathy in Type 2 Diabetic Patients
Hyperkalemia: In IDNT (proteinuria ≥900 mg/day, and serum creatinine ranging from 1.0-3.0 mg/dL), the percent of patients with hyperkalemia (>6 mEq/L) was 18.6% in the irbesartan tablets group versus 6.0% in the placebo group. Discontinuations due to hyperkalemia in the irbesartan tablets group were 2.1% versus 0.4% in the placebo group.
No data are available in regard to overdosage in humans. However, daily doses of 900 mg for 8 weeks were well-tolerated. The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose. Irbesartan is not removed by hemodialysis.Close
To obtain up-to-date information about the treatment of overdosage, a good resource is a certified regional Poison Control Center. Telephone numbers of certified Poison Control Centers are listed in the Physicians’ Desk Reference (PDR). In managing overdose, consider the possibilities of multiple-drug interactions, drug-drug interactions, and unusual drug kinetics in the patient.
Laboratory determinations of serum levels of irbesartan are not widely available, and such determinations have, in any event, no known established role in the management of irbesartan overdose.
Acute oral toxicity studies with irbesartan in mice and rats indicated acute lethal doses were in excess of 2000 mg/kg, about 25- and 50-fold the MRHD (300 mg) on a mg/m2 basis, respectively.
- DOSAGE & ADMINISTRATION
Irbesartan tablets may be administered with other antihypertensive agents and with or without food.Close
The recommended initial dose of irbesartan is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.
A low dose of a diuretic may be added, if blood pressure is not controlled by irbesartan tablets alone. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY: Clinical Studies). Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice-daily dosing.
No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or mild to severe renal impairment.
Nephropathy in Type 2 Diabetic Patients
The recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of irbesartan tablets on diabetic nephropathy (see CLINICAL PHARMACOLOGY: Clinical Studies).
Volume- and Salt-Depleted Patients
A lower initial dose of irbesartan tablets (75 mg) is recommended in patients with depletion of intravascular volume or salt (eg, patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS: Hypotension in Volume- or Salt-Depleted Patients).
- HOW SUPPLIED
Irbesartan tablets USP are available as white to off-white film coated, oval tablets, debossed on one side with “ML 94”, “ML 95” and “ML 96” respectively for 75mg, 150mg and 300mg tablets and plain on the other side.
Unit-of-use bottles contain 30, 90 or 500 tablets and blister packs contain 100 tablets or 90 tablets, as follows:
“ ML 94”
Bottle of 30
Bottle of 90
Bottle of 500
Blister of 100
Blister of 90
Store at 20° C to 25° C (68° F to 77° F); excursions permitted to 15° C to 30° C (59° F to 86° F) [see USP Controlled Room Temperature].
Macleods Pharma USA,INC,
Plainsboro, NJ 08536
Macleods Pharmaceutical Limited
Daman (U.T) INDIA
Rev June 2014
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
See How Supplied section for a complete list of available packages of Irbesartan Tablets.
Macleods Pharmaceuticals Ltd.
Macleods Pharmaceuticals Ltd.
Macleods Pharmaceuticals Ltd.
Macleods Pharmaceuticals Ltd.
100 Tablets (10 x 10 Unit-dose Blisters)
Macleods Pharmaceuticals Ltd.
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33342-047 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IRBESARTAN (UNII: J0E2756Z7N) (IRBESARTAN - UNII:J0E2756Z7N) IRBESARTAN 75 mg Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) POVIDONE K29/32 (UNII: 390RMW2PEQ) TALC (UNII: 7SEV7J4R1U) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 3000 (UNII: SA1B764746) Product Characteristics Color WHITE Score no score Shape OVAL Size 11mm Flavor Imprint Code ML94 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33342-047-07 30 in 1 BOTTLE 2 NDC:33342-047-15 500 in 1 BOTTLE 3 NDC:33342-047-12 10 in 1 CARTON 3 10 in 1 BLISTER PACK 4 NDC:33342-047-10 90 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202254 09/27/2012 IRBESARTAN
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33342-048 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IRBESARTAN (UNII: J0E2756Z7N) (IRBESARTAN - UNII:J0E2756Z7N) IRBESARTAN 150 mg Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) POVIDONE K29/32 (UNII: 390RMW2PEQ) TALC (UNII: 7SEV7J4R1U) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 3000 (UNII: SA1B764746) Product Characteristics Color WHITE Score no score Shape OVAL Size 14mm Flavor Imprint Code ML95 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33342-048-07 30 in 1 BOTTLE 2 NDC:33342-048-15 500 in 1 BOTTLE 3 NDC:33342-048-12 10 in 1 CARTON 3 10 in 1 BLISTER PACK 4 NDC:33342-048-10 90 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202254 09/27/2012 IRBESARTAN
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33342-049 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IRBESARTAN (UNII: J0E2756Z7N) (IRBESARTAN - UNII:J0E2756Z7N) IRBESARTAN 300 mg Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) POVIDONE K29/32 (UNII: 390RMW2PEQ) TALC (UNII: 7SEV7J4R1U) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 3000 (UNII: SA1B764746) Product Characteristics Color WHITE Score no score Shape OVAL Size 17mm Flavor Imprint Code ML96 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33342-049-07 30 in 1 BOTTLE 2 NDC:33342-049-15 500 in 1 BOTTLE 3 NDC:33342-049-39 9 in 1 CARTON 3 10 in 1 BLISTER PACK 4 NDC:33342-049-10 90 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202254 09/27/2012 Labeler - Macleods Pharmaceuticals Limited (862128535) Establishment Name Address ID/FEI Business Operations Macleods Pharmaceuticals Limited 918608365 ANALYSIS(33342-047, 33342-048, 33342-049) , LABEL(33342-047, 33342-048, 33342-049) , MANUFACTURE(33342-047, 33342-048, 33342-049) , PACK(33342-047, 33342-048, 33342-049)