Label: ZYPITAMAG- pitavastatin magnesium tablet, film coated
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NDC Code(s):
70771-1117-0,
70771-1117-1,
70771-1117-3,
70771-1117-4, view more70771-1117-5, 70771-1117-7, 70771-1117-9, 70771-1118-0, 70771-1118-1, 70771-1118-3, 70771-1118-4, 70771-1118-5, 70771-1118-7, 70771-1118-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated August 14, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ZYPITAMAG
pitavastatin magnesium tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1117 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PITAVASTATIN (UNII: M5681Q5F9P) (PITAVASTATIN - UNII:M5681Q5F9P) PITAVASTATIN 2 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) CROSPOVIDONE (UNII: 2S7830E561) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM CARBONATE (UNII: 45P3261C7T) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (off white) Score no score Shape ROUND Size 7mm Flavor Imprint Code 877 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1117-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/09/2018 2 NDC:70771-1117-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/09/2018 3 NDC:70771-1117-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/09/2018 4 NDC:70771-1117-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/09/2018 5 NDC:70771-1117-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/09/2018 6 NDC:70771-1117-4 10 in 1 CARTON 03/09/2018 6 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 7 NDC:70771-1117-7 1 in 1 CARTON 03/09/2018 7 7 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208379 03/09/2018 ZYPITAMAG
pitavastatin magnesium tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1118 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PITAVASTATIN (UNII: M5681Q5F9P) (PITAVASTATIN - UNII:M5681Q5F9P) PITAVASTATIN 4 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) CROSPOVIDONE (UNII: 2S7830E561) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM CARBONATE (UNII: 45P3261C7T) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (off white) Score no score Shape ROUND Size 9mm Flavor Imprint Code 878 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1118-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/09/2018 2 NDC:70771-1118-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/09/2018 3 NDC:70771-1118-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/09/2018 4 NDC:70771-1118-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/09/2018 5 NDC:70771-1118-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/09/2018 6 NDC:70771-1118-4 10 in 1 CARTON 03/09/2018 6 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 7 NDC:70771-1118-7 1 in 1 CARTON 03/09/2018 7 7 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208379 03/09/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1117, 70771-1118) , MANUFACTURE(70771-1117, 70771-1118)
