Label: PITAVASTATIN CALCIUM tablet
- NDC Code(s): 70771-1784-9, 70771-1785-9, 70771-1786-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 3, 2023
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INGREDIENTS AND APPEARANCE
PITAVASTATIN CALCIUM
pitavastatin calcium tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1784 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PITAVASTATIN CALCIUM (UNII: IYD54XEG3W) (PITAVASTATIN - UNII:M5681Q5F9P) PITAVASTATIN 1 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM CARBONATE (UNII: 45P3261C7T) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code 481 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1784-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/02/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206047 11/02/2023 PITAVASTATIN CALCIUM
pitavastatin calcium tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1785 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PITAVASTATIN CALCIUM (UNII: IYD54XEG3W) (PITAVASTATIN - UNII:M5681Q5F9P) PITAVASTATIN 2 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM CARBONATE (UNII: 45P3261C7T) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 7mm Flavor Imprint Code 482 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1785-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/02/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206047 11/02/2023 PITAVASTATIN CALCIUM
pitavastatin calcium tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1786 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PITAVASTATIN CALCIUM (UNII: IYD54XEG3W) (PITAVASTATIN - UNII:M5681Q5F9P) PITAVASTATIN 4 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM CARBONATE (UNII: 45P3261C7T) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 9mm Flavor Imprint Code 483 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1786-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/02/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206047 11/02/2023 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1784, 70771-1785, 70771-1786) , MANUFACTURE(70771-1784, 70771-1785, 70771-1786)
