Rosuvastatin Calcium

Dosage and Administration Modifications Due to Drug Interactions ( 2.6 ) 07/2023 Contraindications, Pregnancy and Lactation ( 4 ) Removed 01/2023 Warnings and Precautions ( 5.2 ) 01/2023 Warnings and Precautions, Concomitant Coumarin Anticoagulants ( 5.4 ) Removed 01/2023

1 INDICATIONS AND USAGE Rosuvastatin tablets are an HMG Co-A reductase inhibitor indicated for: • adult patients with primary hyperlipidemia and mixed dyslipidemia as an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, nonHDL-C, and TG levels and to increase HDLC ( 1.1 ) • pediatric patients 8 to 17 years of age with heterozygous familial hypercholesterotemia (HeFH] to reduce elevated total-C, LDL-C and ApoB after failing an adequate trial of diet therapy ( 1.2 ) • adult patients with hypertriglyceridemia as an adjunct to diet ( 1.3 ) • adult patients with primary dysbetalipoproteinemia [Type III hyperlipoproteinemia) as an adjunct to diet ( 1.4 ) • adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LOL-G, total-G, and ApoB ( 1.5 ) • slowing the progression of atherosclerosis as part of a treatment strategy lo lower total-C and LDL-C as an adjunct to diet ( 1.6 ) • risk reduction of MI, stroke, and arterial revascularization procedures in patients without clinically evident CHD, but with multiple risk factors ( 1.7 ) Limitations of use ( 1.8 ): Rosuvastatin tablets have not been studied in Fredrickson Type I and V dyslipidemias. 1.1 Hyperlipidemia and Mixed Dyslipidemia Rosuvastatin tablets are indicated as adjunctive therapy to diet to reduce elevated Total-C, LDL-C, ApoB, nonHDL-C, and triglycerides and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and nonpharmacological interventions alone has been inadequate. 1.2 Pediatric Patients with Familial Hypercholesterolemia Rosuvastatin tablets are indicated as an adjunct to diet to: • reduce Total-C, LDL-C and ApoB levels in children and adolescents 8 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: LDL-C >190 mg/dL, or >160 mg/dL along with a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors. Pediatric use information for patients 7 to 17 years of age with homozygous familial hypercholesterolemia (HoFH) is approved by AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.3 Hypertriglyceridemia Rosuvastatin tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. 1.4 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia) Rosuvastatin tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia). 1.5 Adult Patients with Homozygous Familial Hypercholesterolemia Rosuvastatin tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia. 1.6 Slowing of the Progression of Atherosclerosis Rosuvastatin tablets are indicated as adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels. 1.7 Primary Prevention of Cardiovascular Disease In individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age ≥50 years old in men and >60 years old in women, hsCRP >2 mg/L, and the presence of at least one additional cardiovascular disease risk factor such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease, rosuvastatin tablets are indicated to: • reduce the risk of stroke • reduce the risk of myocardial infarction • reduce the risk of arterial revascularization procedures 1.8 Limitations of U …

2 DOSAGE AND ADMINISTRATION Take orally with or without food, at any time of day. ( 2.1 ) Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating rosuvastatin tablets, and adjust dosage if necessary. ( 2.1 ) Adults: Recommended dosage range is 5 to 40 mg once daily. ( 2.2 ) Pediatric Patients with HeFH : Recommended dosage range is 5 to 10 mg once daily for patients aged 8 to less than 10 years of age, and 5 to 20 mg once daily for patients aged 10 years and older. ( 2.3 ) Pediatric Patients with HoFH : Recommended dosage is 20 mg once daily for patients aged 7 years and older. ( 2.3 ) Asian Patients : Initiate at 5 mg once daily. Consider risks and benefits of treatment if not adequately controlled at dosages up to 20 mg once daily. ( 2.4 ) Patients with Severe Renal Impairment (not on hemodialysis) : Initiate at 5 mg once daily; do not exceed 10 mg once daily. ( 2.5 ) See full prescribing information for rosuvastatin tablet dosage and administration modifications due to drug interactions. ( 2.6 ) 2.1 General Dosage and Administration Information Administer rosuvastatin tablets orally as a single dose at any time of day, with or without food. Swallow the tablets whole. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating, rosuvastatin tablets and adjust the dosage if necessary. If a dose is missed, advise patients not to take an extra dose. Resume treatment with the next dose. When taking rosuvastatin tablets with an aluminum and magnesium hydroxide combination antacid, administer rosuvastatin tablets at least 2 hours before the antacid [see Drug Interactions (7.2) ]. 2.2 Recommended Dosage in Adult Patients The dosage range for rosuvastatin tablets is 5 to 40 mg orally once daily. The recommended dosage of rosuvastatin tablets depends on a patient’s indication for usage, LDL-C, and individual risk for CV events. 2.3 Recommended Dosage in Pediatric Patients Dosage in Pediatric Patients 8 Years of Age and Older with HeFH The recommended dosage range is 5 mg to 10 mg orally once daily in patients aged 8 years to less than 10 years and 5 mg to 20 mg orally once daily in patients aged 10 years and older. Dosage in Pediatric Patients 7 Years of Age and Older with HoFH The recommended dosage is 20 mg orally once daily. 2.4 Recommended Dosage in Asian Patients Initiate rosuvastatin tablets at 5 mg once daily due to increased rosuvastatin plasma concentrations. Consider the risks and benefits of rosuvastatin tablets when treating Asian patients not adequately controlled at doses up to 20 mg once daily [see Warnings and Precautions (5.1) , Use in Specific Populations (8.8) , and Clinical Pharmacology (12.3) ] . 2.5 Recommended Dosage in Patients with Renal Impairment In patients with severe renal impairment (CL cr less than 30 mL/min/1.73 m 2 ) not on hemodialysis, the recommended starting dosage is 5 mg once daily and should not exceed 10 mg once daily [see Warnings and Precautions (5.1) and Use in Specific Populations (8.6) ] . There are no dosage adjustment recommendations for patients with mild and moderate renal impairment. 2.6 Dosage Modifications Due to Drug Interactions Table 1 displays dosage modifications for Rosuvastatin tablets due to drug interactions [see Warnings and Precautions (5.1) and Drug Interactions (7.1) ] . Table 1: Rosuvastatin Tablets Dosage Modifications Due to Drug Interactions​​​​​​​​​​​​​​​​​​​​​ Concomitantly Used Drug Rosuvastatin tablets Dosage Modifications Sofosbuvir/velpatasvir/voxilaprevir or Ledipasvir/sofosbuvir Avoid concomitant use. Gemfibrozil Avoid concomitant use. If use is unavoidable, initiate at 5 mg once daily and do not exceed 10 mg once daily. Tafamidis Avoid concomitant use. If use is unavoidable, initiate at 5 mg once daily and do not exceed 20 mg once daily. Belumosudil Do not exceed 5 mg once daily. Cyclosporine Do not exceed 5 mg once daily. Darolutamide Do not exceed 5 mg once daily. Additional Antiviral Medications Simeprevir Dasa …

3 DOSAGE FORMS AND STRENGTHS ​​​​​​​5 mg of rosuvastatin: Pink, round, biconvex, beveled edge, film coated tablets debossed with “R5” on one side and plain on other side. 10 mg of rosuvastatin: Pink, round, biconvex, beveled edge, film coated tablets debossed with “R10” on one side and plain on other side. 20 mg of rosuvastatin: Pink, round, biconvex, film coated tablets debossed with “R20” on one side and plain on other side. 40 mg of rosuvastatin: Pink, oval, biconvex, film-coated tablets debossed with “R40” on one side and plain on other side. Tablets: 5 mg, 10 mg, 20 mg, and 40 mg of rosuvastatin. ( 3 )

4 CONTRAINDICATIONS Rosuvastatin tablets are contraindicated in the following conditions: • Patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin tablets [see Adverse Reactions (6.1) ]. • Patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels [see Warnings and Precautions (5.3) ]. • Pregnancy [see Use in Specific Populations (8.1 , 8.3) ]. • Lactation. Limited data indicate that rosuvastatin is present in human milk. Because statins have the potential for serious adverse reactions in nursing infants, women who require rosuvastatin treatment should not breastfeed their infants [see Use in Specific Populations (8.2) ]. • Known hypersensitivity to product components ( 4 ) • Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels ( 4 ) • Pregnancy ( 4 , 8.1 , 8.3 ) • Lactation ( 4 , 8.2 )

6 ADVERSE REACTIONS Most frequent adverse reactions (rate ≥2%) are headache, myalgia, abdominal pain, asthenia, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact PuraCap Laboratories, LLC DBA Blu Pharmaceuticals at 1-888-374-2791 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious adverse reactions are discussed in greater detail in other sections of the label: • Rhabdomyolysis with myoglobinuria and acute renal failure and myopathy (including myositis) [see Warnings and Precautions (5.1 ) ] • Liver enzyme abnormalities (see Warnings and Precautions (5.3) ] 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. In the rosuvastatin controlled clinical trials database (placebo or active-controlled) of 5394 patients with a mean treatment duration of 15 weeks, 1.4% of patients discontinued due to adverse reactions. The most common adverse reactions that led to treatment discontinuation were: • myalgia • abdominal pain • nausea The most commonly reported adverse reactions (incidence >2%) in the rosuvastatin controlled clinical trial database of 5394 patients were: • Headache • myalgia • abdominal pain • Asthenia • nausea Adverse reactions reported in >2% of patients in placebo-controlled clinical studies and at a rate greater than placebo are shown in Table 1. These studies had a treatment duration of up to 12 weeks. Table 1. Adverse Reactions Reported in ≥2% of Patients Treated with Rosuvastatin and > Placebo in Placebo-Controlled Trials (% of Patients) 1 Adverse reactions by COSTART preferred term Other adverse reactions reported in clinical studies were abdominal pain, dizziness, hypersensitivity (including rash, pruritus, urticaria, and angioedema) and pancreatitis. The following laboratory abnormalities have also been reported: dipstick-positive proteinuria and microscopic hematuria [see Warnings and Precautions (5.5) ]; elevated creatine phosphokinase, transaminases, glucose, glutamyl transpeptidase, alkaline phosphatase, and bilirubin; and thyroid function abnormalities. In the clinical trial, involving 981 participants treated with rosuvastatin 40 mg (n=700) or placebo (n=281) with a mean treatment duration of 1.7 years, 5.6% of subjects treated with rosuvastatin versus 2.8% of placebo-treated subjects discontinued due to adverse reactions. The most common adverse reactions that led to treatment discontinuation were: myalgia, hepatic enzyme increased, headache, and nausea [see Clinical Studies (14.8) ]. Adverse reactions reported in >2% of patients and at a rate greater than placebo are shown in Table 2. Table 2. Adverse Reactions Reported in >2% of Patients Treated With Rosuvastatin and > Placebo in a Trial (% of Patients) 1 Adverse reactions by MedDRA preferred term. 2 Frequency recorded as abnormal laboratory value. In the clinical trial, 17,802 participants were treated with rosuvastatin 20 mg (n=8901) or placebo (n=8901) for a mean duration of 2 years. A higher percentage of rosuvastatin-treated patients versus placebo-treated patients, 6.6% and 6.2%, respectively, discontinued study medication due to an adverse event, irrespective of treatment causality. Myalgia was the most common adverse reaction that led to treatment discontinuation. In the clinical trial, there was a significantly higher frequency of diabetes mellitus reported in patients taking rosuvastatin (2.8%) versus patients taking placebo (2.3%). Mean HbA1c was significantly increased by 0.1% in rosuvastatin-treated patients compared to placebo-treated patients. The number of patients with a HbA1c >6.5% at the end of the trial was significantly higher in rosuvastatin-treated versus placebo-treated patients [see Warnings and Precautions (5.6) and Clinical Studies (14.9) ]. …

7 DRUG INTERACTIONS See full prescribing information for details regarding concomitant use of rosuvastatin tablets with other drugs that increase the risk of myopathy and rhabdomyolysis. ( 7.1 ) Aluminum and Magnesium Hydroxide Combination Antacids : Administer rosuvastatin tablets at least 2 hours before the antacid. ( 7.2 ) Warfarin : Obtain INR prior to starting rosuvastatin tablets. Monitor INR frequently until stable upon initiation, dose titration or discontinuation. ( 7.3 ) 7.1 Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Rosuvastatin Tablets Rosuvastatin is a substrate of CYP2C9 and transporters (such as OATP1B1, BCRP). Rosuvastatin plasma levels can be significantly increased with concomitant administration of inhibitors of CYP2C9 and transporters. Table 5 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when used concomitantly with rosuvastatin tablets and instructions for preventing or managing them [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ] . Table 5: Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Rosuvastatin Tablets Sofosbuvir/velpatasvir/voxilaprevir or Ledipasvir/sofosbuvir Prevention or Management: Avoid concomitant use with rosuvastatin tablets. Mechanism and Clinical Effect(s): Rosuvastatin plasma levels were significantly increased with concomitant administration of many anti-viral drugs, which increases the risk of myopathy and rhabdomyolysis. Gemfibrozil Prevention or Management: Avoid concomitant use of gemfibrozil with rosuvastatin tablets. If use is unavoidable, initiate rosuvastatin tablets at 5 mg once daily and do not exceed a dosage of rosuvastatin tablets 10 mg once daily. Mechanism and Clinical Effect(s): Gemfibrozil significantly increased rosuvastatin exposure and gemfibrozil may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Tafamidis Prevention or Management: Avoid concomitant use of tafamidis with rosuvastatin tablets. If use is unavoidable, initiate rosuvastatin tablets at 5 mg once daily and do not exceed a dosage of rosuvastatin tablets 20 mg once daily. Monitor for signs of myopathy and rhabdomyolysis if used concomitantly with rosuvastatin tablets. Mechanism and Clinical Effect(s): Tafamidis significantly increased rosuvastatin exposure and tafamidis may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Belumosudil Prevention or Management: In patients taking belumosudil, do not exceed a dosage of rosuvastatin tablets 5 mg once daily . Mechanism and Clinical Effect(s): Belumosudil increased rosuvastatin exposure more than 4.6-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Cyclosporine Prevention or Management: In patients taking cyclosporine, do not exceed a dosage of rosuvastatin tablets 5 mg once daily. Mechanism and Clinical Effect(s): Cyclosporine increased rosuvastatin exposure 7-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Darolutamide Prevention or Management: In patients taking darolutamide, do not exceed a dosage of rosuvastatin tablets 5 mg once daily. Mechanism and Clinical Effect(s): Darolutamide increased rosuvastatin exposure more than 5-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Additional Anti-Viral Medications Prevention or Management: Simeprevir Dasabuvir/ombitasvir/paritaprevir/ritonavir Elbasvir/grazoprevir Sofosbuvir/velpatasvir Glecaprevir/pibrentasvir Atazanavir/ritonavir Lopinavir/ritonavir Initiate with rosuvastatin tablets 5 mg once daily, and do not exceed a dosage of rosuvastatin tablets 10 mg once daily. Mechanism and Clinical Effect(s): Rosuvastatin plasma levels were significantly increased with concomitant administration of many anti-viral drugs, which increases the risk of myopathy and rhabdomyolysis. Capmatinib P …

8 USE IN SPECIFIC POPULATIONS Pregnancy : May cause fetal harm. ( 8.1 ) Lactation : Breastfeeding not recommended during treatment with rosuvastatin tablets. ( 8.2 ) 8.1 Pregnancy Risk Summary Discontinue rosuvastatin tablets when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Rosuvastatin tablets decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, rosuvastatin tablets may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1) ] . In addition, treatment of hypercholesterolemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia for most patients. Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations. Published data from prospective and retrospective observational cohort studies with rosuvastatin tablets use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see Data) . In animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered rosuvastatin during the period of organogenesis at doses that resulted in systemic exposures equivalent to human exposures at the maximum recommended human dose (MRHD) of 40 mg/day, based on AUC and body surface area (mg/m 2 ), respectively (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data A Medicaid cohort linkage study of 1152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity score-based methods. The relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus. There were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders. In the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births. Animal Data In female rats given 5, 15 and 50 mg/kg/day before mating and continuing through to gestation day 7 resulted in decreased fetal body weight (female pups) and delayed ossification at 50 mg/kg/day (10 times the human exposure at the MRHD dose of 40 mg/day based on AUC). In pregnant rats given 2, 10 and 50 mg/kg/day of rosuvastatin from gestation day 7 through lactation day 21 (weaning), decreased pup survival occurred at 50 mg/kg/day (dose equivalent to 12 times the MRHD of 40 mg/day based body surface area). In pregnant rabbits given 0.3, 1, and 3 mg/kg/day of rosuvastatin from gestation day 6 to day 18, decreased fetal viability and maternal mortality was observed at 3 …

12.1 Mechanism of Action Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol. In vivo studies in animals, and in vitro studies in cultured animal and human cells have shown rosuvastatin to have a high uptake into, and selectivity for, action in the liver, the target organ for cholesterol lowering. In in vivo and in vitro studies, rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell-surface to enhance uptake and catabolism of LDL. Second, rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

11 DESCRIPTION Rosuvastatin calcium USP is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium USP is 6-Heptenoic acid, 7-[4-(4-fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl) amino]-5-pyrimidinyl]-3,5-dihydroxy-, calcium salt (2:1), (3R,5S,6E) with the following structural formula: The empirical formula for rosuvastatin calcium USP is (C 22 H 27 FN 3 O 6 S) 2 Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a White or almost white, hygroscopic powder that is freely soluble in methylene chloride, slightly soluble in water practically insoluble in anhydrous ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: Each tablet contains: crospovidone USP, hypromellose USP, iron oxide red NF, lactose monohydrate USP, magnesium stearate USP, microcrystalline cellulose USP, sodium bicarbonate powder NF, titanium dioxide USP, triacetin USP. structural_formula

10 OVERDOSAGE No specific antidotes for rosuvastatin tablets are known. Hemodialysis does not significantly enhance clearance of rosuvastatin. In the event of overdose, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin tablets USP are supplied as: • NDC 24658-261-90: 5 mg. Yellow, round, biconvex, film-coated tablets, debossed with '5'· on one side and 'B' on other side; bottle of 90 tablets • NDC 24658-261-05: 5 mg, Yellow, round, biconvex, film-coated tablets, debossed with ‘5’ on one side and ‘B’ on other side; bottle of 500 tablets. • NDC 24658-262-45: 10 mg. Pink, round, biconvex, film-coated tablets, debossed with '10' on one side and 'B' on other side; bottle of 45 tablets • NDC 24658-262-90: 10 mg. Pink, round, biconvex, film-coated tablets, debossed with '10' on one side and 'B' on other side; bottle of 90 tablets • NDC 24658-262-05: 10 mg, Pink, round, biconvex, film-coated tablets, debossed with ‘10’ on one side and ‘B’ on other side; bottle of 500 tablets • NDC 24658-263-45: 20 mg. Pink, round, biconvex, film-coated tablets, debossed with '20' on one side and 'B' on other side; bottle of 45 tablets • NDC 24658-263-90: 20 mg. Pink, round, biconvex, film-coated tablets, debossed with '20' on one side and 'B' on other side; bottle of 90 tablets • NDC 24658-263-05: 20 mg, Pink, round, biconvex, film-coated tablets, debossed with ‘20’ on one side and ‘B’ on other side; bottle of 500 tablets • NDC 24658-264-30: 40 mg. Pink, oval, biconvex, film-coated tablets, debossed with '40' on one side and 'B' on other side; bottle of 30 tablets • NDC 24658-264-45: 40 mg. Pink, oval, biconvex, film-coated tablets, debossed with '40' on one side and 'B' on other side; bottle of 45 tablets • NDC 24658-264-90: 40 mg. Pink, oval, biconvex, film-coated tablets, debossed with '40' on one side and 'B' on other side; bottle of 90 tablets • NDC 24658-264-05: 40mg, Pink, oval, biconvex, film-coated tablets, debossed with ‘40’ on one side and ‘B’ on other side; bottle of 500 tablets Storage Store at 20· to 25°C (6B0 to 77°F). [See USP controlled room temperature). Protect from moisture.