ATORVASTATIN CALCIUM tablet
atorvastatin calcium by
Drug Labeling and Warnings
atorvastatin calcium by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL
NDC: 70771-1875-9
Atorvastatin Calcium Tablets, USP 10 mg
Rx Only
90 Tablets
NDC: 70771-1876-9
Atorvastatin Calcium Tablets, USP 20 mg
Rx Only
90 Tablets
NDC: 70771-1877-9
Atorvastatin Calcium Tablets, USP 40 mg
Rx Only
90 Tablets
NDC: 70771-1878-9
Atorvastatin Calcium Tablets, USP 80 mg
Rx Only
90 Tablets
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INGREDIENTS AND APPEARANCE
ATORVASTATIN CALCIUM
atorvastatin calcium tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 70771-1875 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN 10 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE (white to off-white) Score no score Shape OVAL (OVAL) Size 8mm Flavor Imprint Code 1777 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70771-1875-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 06/12/2024 2 NDC: 70771-1875-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 06/12/2024 3 NDC: 70771-1875-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 06/12/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206536 06/12/2024 ATORVASTATIN CALCIUM
atorvastatin calcium tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 70771-1876 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN 20 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE (white to off-white) Score no score Shape OVAL (OVAL) Size 10mm Flavor Imprint Code 1775 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70771-1876-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 06/12/2024 2 NDC: 70771-1876-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 06/12/2024 3 NDC: 70771-1876-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 06/12/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206536 06/12/2024 ATORVASTATIN CALCIUM
atorvastatin calcium tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 70771-1877 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN 40 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE SODIUM PHOSPHATE (UNII: E6S1NJ4Y5Q) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE (white to off-white) Score no score Shape OVAL (OVAL) Size 13mm Flavor Imprint Code 1772 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70771-1877-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 06/12/2024 2 NDC: 70771-1877-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 06/12/2024 3 NDC: 70771-1877-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 06/12/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206536 06/12/2024 ATORVASTATIN CALCIUM
atorvastatin calcium tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 70771-1878 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN 80 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE (white to off-white) Score no score Shape OVAL (OVAL) Size 17mm Flavor Imprint Code 1770 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70771-1878-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 06/12/2024 2 NDC: 70771-1878-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 06/12/2024 3 NDC: 70771-1878-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 06/12/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206536 06/12/2024 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1875, 70771-1876, 70771-1877, 70771-1878) , MANUFACTURE(70771-1875, 70771-1876, 70771-1877, 70771-1878)
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