Active ingredient
Topiramate
295 finished FDA listings contain Topiramate as their only active ingredient; 16 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- TOPIRAMATE
- Dosage forms
- Capsule, Capsule, Coated Pellets, Capsule, Extended Release, Solution, Tablet, Tablet, Coated, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 50
- Strengths listed
- 100 mg/1 · 15 mg/1 · 150 mg/1 · 200 mg/1 · 25 mg/1 · 25 mg/ml · 50 mg/1
- Brand names in FDA listings
- Eprontia, Qudexy Xr, Topamax, Trokendi Xr
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 38404
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 020505 | JANSSEN PHARMS | 1996-12-24 | 4 |
| NDA 020844 | JANSSEN PHARMS | 1998-10-26 | 2 |
| ANDA 090162 | UNICHEM LABS LTD | 2009-03-27 | 35 |
| ANDA 090278 | SUN PHARM | 2009-03-27 | 22 |
| ANDA 079162 | INVAGEN PHARMS | 2009-03-27 | 13 |
| ANDA 077627 | GLENMARK PHARMS LTD | 2009-03-27 | 11 |
| ANDA 078235 | ZYDUS PHARMS USA INC | 2009-03-27 | 51 |
| ANDA 078462 | AUROBINDO PHARMA | 2009-03-27 | 9 |
| ANDA 076343 | CIPLA LTD | 2009-03-27 | 36 |
| ANDA 078877 | ZYDUS PHARMS USA INC | 2009-10-14 | 7 |
| NDA 201635 | SUPERNUS PHARMS | 2013-08-16 | 4 |
| NDA 205122 | UPSHER SMITH LABS | 2014-03-11 | 10 |
| ANDA 207382 | ZYDUS | 2017-11-24 | 8 |
| ANDA 210278 | GLENMARK PHARMS LTD | 2021-02-01 | 10 |
| ANDA 215414 | ASCENT PHARMS INC | 2021-08-26 | 8 |
| NDA 214679 | AZURITY | 2021-11-05 | 1 |
| ANDA 208949 | ZYDUS | 2022-11-28 | 10 |
| ANDA 205976 | PH HEALTH | 2023-03-01 | 4 |
| ANDA 206210 | ACTAVIS LABS FL | 2023-03-10 | 8 |
| ANDA 215663 | AJANTA PHARMA LTD | 2023-08-15 | 4 |
| ANDA 215449 | AUROBINDO PHARMA LTD | 2023-09-27 | 2 |
| ANDA 217231 | DR REDDYS | 2023-11-17 | 4 |
| ANDA 217694 | TWI PHARMS | 2023-12-05 | 4 |
| ANDA 218482 | ALKEM LABS LTD | 2024-06-13 | 2 |
| ANDA 215561 | LUPIN | 2024-07-11 | 4 |
| ANDA 217869 | GLENMARK PHARMS LTD | 2024-07-16 | 2 |
| ANDA 217795 | ALKEM LABS LTD | 2024-10-31 | 3 |
| ANDA 215638 | XIAMEN LP PHARM CO | 2024-11-05 | 5 |
| ANDA 216683 | RUBICON RESEARCH | 2025-05-27 | 3 |
| ANDA 219564 | AJANTA PHARMA LTD | 2025-09-02 | 5 |
| ANDA 217443 | ASCENT PHARMS INC | 2026-01-12 | 4 |
Official labeling on DailyMed
- QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, LLC] · version 30 · 2026-09-10
- TOPIRAMATE CAPSULE, EXTENDED RELEASE [PAR HEALTH USA, LLC] · version 26 · 2026-09-07
- TOPIRAMATE TABLET, FILM COATED [REMEDYREPACK INC.] · version 3 · 2026-09-07
- TOPIRAMATE CAPSULE, EXTENDED RELEASE [PAR HEALTH USA, LLC] · version 16 · 2026-09-07
- TOPIRAMATE CAPSULE, COATED PELLETS [REMEDYREPACK INC.] · version 4 · 2026-09-02
- TOPIRAMATE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS, INC.] · version 9 · 2026-08-28
- TOPIRAMATE TABLET, FILM COATED [COUPLER LLC] · version 1 · 2026-08-28
- TOPIRAMATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, LLC] · version 23 · 2026-08-20
- TOPIRAMATE TABLET, FILM COATED [COUPLER LLC] · version 1 · 2026-08-05
- TOPIRAMATE TABLET, FILM COATED [REMEDYREPACK INC.] · version 7 · 2026-08-03
- TOPIRAMATE TABLET [REMEDYREPACK INC.] · version 10 · 2026-08-03
- TOPIRAMATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] · version 35 · 2026-07-31
Showing the 12 most recent of 152 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.