Label: TOPIRAMATE capsule, extended release
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NDC Code(s):
70771-1315-1,
70771-1315-2,
70771-1315-3,
70771-1315-4, view more70771-1315-5, 70771-1315-9, 70771-1316-1, 70771-1316-2, 70771-1316-3, 70771-1316-4, 70771-1316-5, 70771-1316-9, 70771-1317-1, 70771-1317-2, 70771-1317-3, 70771-1317-4, 70771-1317-5, 70771-1317-9
- 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
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INGREDIENTS AND APPEARANCE
TOPIRAMATE
topiramate capsule, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1315 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 ALCOHOL (UNII: 3K9958V90M) AMMONIA (UNII: 5138Q19F1X) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) ISOPROPYL ALCOHOL (UNII: ND2M416302) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE (WHITE OPAQUE) , WHITE (WHITE OPAQUE) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code 863 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1315-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2018 2 NDC:70771-1315-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2018 3 NDC:70771-1315-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2018 4 NDC:70771-1315-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2018 5 NDC:70771-1315-4 10 in 1 CARTON 04/05/2018 5 NDC:70771-1315-2 10 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 ANDA ANDA207382 04/05/2018 TOPIRAMATE
topiramate capsule, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1316 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 ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B) ISOPROPYL ALCOHOL (UNII: ND2M416302) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TALC (UNII: 7SEV7J4R1U) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) GELATIN (UNII: 2G86QN327L) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) ALCOHOL (UNII: 3K9958V90M) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) AMMONIA (UNII: 5138Q19F1X) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE (WHITE OPAQUE) , WHITE (WHITE OPAQUE) Score no score Shape CAPSULE Size 21mm Flavor Imprint Code 864 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1316-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2018 2 NDC:70771-1316-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2018 3 NDC:70771-1316-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2018 4 NDC:70771-1316-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2018 5 NDC:70771-1316-4 10 in 1 CARTON 04/05/2018 5 NDC:70771-1316-2 10 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 ANDA ANDA207382 04/05/2018 TOPIRAMATE
topiramate capsule, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1317 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 ALCOHOL (UNII: 3K9958V90M) AMMONIA (UNII: 5138Q19F1X) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) ISOPROPYL ALCOHOL (UNII: ND2M416302) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE (WHITE OPAQUE) , WHITE (WHITE OPAQUE) Score no score Shape CAPSULE Size 23mm Flavor Imprint Code 769 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1317-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2018 2 NDC:70771-1317-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2018 3 NDC:70771-1317-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2018 4 NDC:70771-1317-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2018 5 NDC:70771-1317-4 10 in 1 CARTON 04/05/2018 5 NDC:70771-1317-2 10 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 ANDA ANDA207382 04/05/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1315, 70771-1316, 70771-1317) , MANUFACTURE(70771-1315, 70771-1316, 70771-1317)
