Label: ATORVASTATIN CALCIUM tablet
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NDC Code(s):
70771-1443-0,
70771-1443-1,
70771-1443-3,
70771-1443-4, view more70771-1443-5, 70771-1443-9, 70771-1444-0, 70771-1444-1, 70771-1444-3, 70771-1444-4, 70771-1444-5, 70771-1444-9, 70771-1445-0, 70771-1445-1, 70771-1445-3, 70771-1445-4, 70771-1445-5, 70771-1445-9, 70771-1446-0, 70771-1446-1, 70771-1446-3, 70771-1446-4, 70771-1446-5, 70771-1446-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 31, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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:70771-1443 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 (110000 WAMW) (UNII: 5Y0974F5PW) 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 9mm Flavor Imprint Code 249 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1443-4 10 in 1 CARTON 11/21/2018 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:70771-1443-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2018 3 NDC:70771-1443-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2018 4 NDC:70771-1443-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2018 5 NDC:70771-1443-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2018 6 NDC:70771-1443-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206536 11/21/2018 ATORVASTATIN CALCIUM
atorvastatin calcium tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1444 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 (110000 WAMW) (UNII: 5Y0974F5PW) 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 11mm Flavor Imprint Code 250 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1444-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2018 2 NDC:70771-1444-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2018 3 NDC:70771-1444-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2018 4 NDC:70771-1444-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2018 5 NDC:70771-1444-4 10 in 1 CARTON 11/21/2018 5 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 6 NDC:70771-1444-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206536 11/21/2018 ATORVASTATIN CALCIUM
atorvastatin calcium tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1445 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 (110000 WAMW) (UNII: 5Y0974F5PW) 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 14mm Flavor Imprint Code 251 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1445-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2018 2 NDC:70771-1445-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2018 3 NDC:70771-1445-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2018 4 NDC:70771-1445-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2018 5 NDC:70771-1445-4 10 in 1 CARTON 11/21/2018 5 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 6 NDC:70771-1445-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206536 11/21/2018 ATORVASTATIN CALCIUM
atorvastatin calcium tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1446 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 (110000 WAMW) (UNII: 5Y0974F5PW) 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 19mm Flavor Imprint Code 252 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1446-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2018 2 NDC:70771-1446-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2018 3 NDC:70771-1446-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2018 4 NDC:70771-1446-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2018 5 NDC:70771-1446-4 10 in 1 CARTON 11/21/2018 5 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 6 NDC:70771-1446-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206536 11/21/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1443, 70771-1444, 70771-1445, 70771-1446) , MANUFACTURE(70771-1443, 70771-1444, 70771-1445, 70771-1446)