Label: TOPIRAMATE tablet, film coated
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NDC Code(s):
65841-647-01,
65841-647-05,
65841-647-14,
65841-647-16, view more65841-648-01, 65841-648-05, 65841-648-14, 65841-648-16, 65841-649-01, 65841-649-05, 65841-649-14, 65841-649-16, 65841-650-01, 65841-650-05, 65841-650-14, 65841-650-16
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 27, 2023
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-647-14 in bottle of 60 tablets
Topiramate Tablets USP, 25 mg
60 tablets
Rx only
NDC 65841-648-14 in bottle of 60 tablets
Topiramate Tablets USP, 50 mg
60 tablets
Rx only
NDC 65841-649-14 in bottle of 60 tablets
Topiramate Tablets USP, 100 mg
60 tablets
Rx only
NDC 65841-650-14 in bottle of 60 tablets
Topiramate Tablets USP, 200 mg
60 tablets
Rx only
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INGREDIENTS AND APPEARANCE
TOPIRAMATE
topiramate tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-647 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE 25 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code ZD;16 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-647-14 60 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2009 2 NDC:65841-647-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2009 3 NDC:65841-647-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2009 4 NDC:65841-647-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078235 03/27/2009 TOPIRAMATE
topiramate tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-648 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE 50 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 7mm Flavor Imprint Code ZD;15 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-648-14 60 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2009 2 NDC:65841-648-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2009 3 NDC:65841-648-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2009 4 NDC:65841-648-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078235 03/27/2009 TOPIRAMATE
topiramate tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-649 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE 100 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 10mm Flavor Imprint Code ZD;14 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-649-14 60 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2009 2 NDC:65841-649-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2009 3 NDC:65841-649-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2009 4 NDC:65841-649-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078235 03/27/2009 TOPIRAMATE
topiramate tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-650 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE 200 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 12mm Flavor Imprint Code ZD;13 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-650-14 60 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2009 2 NDC:65841-650-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2009 3 NDC:65841-650-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2009 4 NDC:65841-650-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078235 03/27/2009 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-647, 65841-648, 65841-649, 65841-650) , MANUFACTURE(65841-647, 65841-648, 65841-649, 65841-650)