Label: ATORVASTATIN CALCIUM tablet
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NDC Code(s):
70771-1875-0,
70771-1875-5,
70771-1875-9,
70771-1876-0, view more70771-1876-5, 70771-1876-9, 70771-1877-0, 70771-1877-5, 70771-1877-9, 70771-1878-0, 70771-1878-5, 70771-1878-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 17, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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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)
