Topiramate
- Product NDC
- 47335-710
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA090278
- Marketing category
- ANDA
- Substance
- TOPIRAMATE
- Current FDA listing
- Yes
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|
| 47335-710-08 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-710-08) | 2014-12-15 | | No | Historical |
| 47335-710-13 | 500 TABLET, FILM COATED in 1 BOTTLE (47335-710-13) | 2014-12-15 | | No | Historical |
| 47335-710-18 | 1000 TABLET, FILM COATED in 1 BOTTLE (47335-710-18) | 2014-12-15 | | No | Historical |
| 47335-710-83 | 30 TABLET, FILM COATED in 1 BOTTLE (47335-710-83) | 2014-12-15 | | No | Historical |
| 47335-710-86 | 60 TABLET, FILM COATED in 1 BOTTLE (47335-710-86) | 2014-12-15 | | No | Historical |
| 47335-710-88 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-710-88) | 2014-12-15 | | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 | Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited | 2026-04-03 | Human Prescription Drug Label | 22 |
| These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 | PD-Rx Pharmaceuticals, Inc. | 2025-07-17 | HUMAN PRESCRIPTION DRUG LABEL | 24 |
| These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 | Bryant Ranch Prepack | 2024-08-20 | HUMAN PRESCRIPTION DRUG LABEL | 105 |
| These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 | NuCare Pharmaceuticals,Inc. | 2024-06-20 | HUMAN PRESCRIPTION DRUG LABEL | 3 |
| These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 | Proficient Rx LP | 2023-07-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |
| These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 | A-S Medication Solutions | 2021-04-16 | Human Prescription Drug Label | 6 |
| These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996 | Apotheca Inc. | 2016-06-20 | HUMAN PRESCRIPTION DRUG LABEL | 4 |