Label: PRAVASTATIN SODIUM tablet
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NDC Code(s):
65841-739-05,
65841-739-16,
65841-740-05,
65841-740-10, view more65841-740-16, 65841-741-05, 65841-741-16, 65841-742-05, 65841-742-16
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated October 13, 2022
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-739-05 in bottle of 500 tablets
Pravastatin Sodium Tablets USP, 10 mg
Rx only
500 tablets
NDC 65841-740-05 in bottle of 500 tablets
Pravastatin Sodium Tablets USP, 20 mg
Rx only
500 tablets
NDC 65841-741-05 in bottle of 500 tablets
Pravastatin Sodium Tablets USP, 40 mg
Rx only
500 tablets
NDC 65841-742-05 in bottle of 500 tablets
Pravastatin Sodium Tablets USP, 80 mg
Rx only
500 tablets
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INGREDIENTS AND APPEARANCE
PRAVASTATIN SODIUM
pravastatin sodium tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-739 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:KXO2KT9N0G) PRAVASTATIN SODIUM 10 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O) SODIUM CARBONATE (UNII: 45P3261C7T) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape OVAL (OVAL) Size 9mm Flavor Imprint Code ZC46 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-739-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2010 2 NDC:65841-739-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077751 03/30/2010 PRAVASTATIN SODIUM
pravastatin sodium tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-740 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:KXO2KT9N0G) PRAVASTATIN SODIUM 20 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O) SODIUM CARBONATE (UNII: 45P3261C7T) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape OVAL (OVAL) Size 11mm Flavor Imprint Code ZC45 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-740-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2010 2 NDC:65841-740-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2010 3 NDC:65841-740-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077751 03/30/2010 PRAVASTATIN SODIUM
pravastatin sodium tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-741 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:KXO2KT9N0G) PRAVASTATIN SODIUM 40 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O) SODIUM CARBONATE (UNII: 45P3261C7T) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape OVAL (OVAL) Size 14mm Flavor Imprint Code ZC44 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-741-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2010 2 NDC:65841-741-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077751 03/30/2010 PRAVASTATIN SODIUM
pravastatin sodium tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-742 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:KXO2KT9N0G) PRAVASTATIN SODIUM 80 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O) SODIUM CARBONATE (UNII: 45P3261C7T) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape OVAL (OVAL) Size 19mm Flavor Imprint Code ZC43 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-742-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2010 2 NDC:65841-742-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077751 03/30/2010 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 677605858 ANALYSIS(65841-739, 65841-740, 65841-741, 65841-742) , MANUFACTURE(65841-739, 65841-740, 65841-741, 65841-742)