Active ingredient
Carbamazepine
155 finished FDA listings contain Carbamazepine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CARBAMAZEPINE
- Dosage forms
- Capsule, Extended Release, Suspension, Tablet, Tablet, Chewable, Tablet, Extended Release, Tablet, Film Coated, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 45
- Strengths listed
- 100 mg/1 · 100 mg/5ml · 200 mg/1 · 200 mg/10ml · 300 mg/1 · 400 mg/1
- Brand names in FDA listings
- Carbamazepin, Carbamazepine Er, Carbatrol, Equetro, Tegretol, Tegretol Xr
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2002
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 016608 | NOVARTIS | 1968-03-11 | 1 |
| ANDA 070541 | TEVA | 1986-09-17 | 1 |
| NDA 018927 | NOVARTIS | 1987-12-18 | 1 |
| NDA 020234 | NOVARTIS | 1996-03-25 | 3 |
| ANDA 074649 | TARO | 1996-10-03 | 8 |
| NDA 020712 | TAKEDA PHARMS USA | 1997-09-30 | 3 |
| ANDA 075687 | TARO PHARM INDS | 2000-10-24 | 6 |
| ANDA 075712 | TORRENT PHARMS | 2001-07-05 | 5 |
| ANDA 075948 | APOTEX | 2002-02-27 | 9 |
| ANDA 075714 | CHARTWELL RX | 2002-06-05 | 4 |
| ANDA 076729 | TARO | 2004-09-20 | 2 |
| NDA 021710 | VALIDUS PHARMS | 2004-12-10 | 3 |
| ANDA 077272 | TORRENT PHARMS | 2005-12-07 | 3 |
| ANDA 078115 | TARO | 2009-03-31 | 7 |
| ANDA 076697 | ANI PHARMS | 2011-05-20 | 6 |
| ANDA 078986 | APOTEX INC | 2011-11-25 | 15 |
| ANDA 205571 | ZYDUS PHARMS | 2019-02-07 | 8 |
| ANDA 207798 | UMEDICA | 2020-04-15 | 10 |
| ANDA 211623 | UNIQUE PHARM | 2020-04-24 | 5 |
| ANDA 213311 | CSPC OUYI | 2021-04-13 | 3 |
| ANDA 212948 | ANBISON LAB | 2021-09-30 | 2 |
| ANDA 215591 | ZHEJIANG JIUZHOU | 2022-03-31 | 6 |
| ANDA 216594 | UMEDICA | 2022-08-18 | 14 |
| ANDA 213284 | UNICHEM | 2022-08-22 | 3 |
| ANDA 214277 | NOVITIUM PHARMA | 2022-10-06 | 1 |
| ANDA 216404 | INGENUS PHARMS LLC | 2022-12-02 | 3 |
| ANDA 216235 | SCIECURE PHARMA INC | 2023-03-02 | 3 |
| ANDA 216193 | AJANTA PHARMA LTD | 2023-03-24 | 3 |
| ANDA 218221 | BIONPHARMA | 2024-02-16 | 3 |
| ANDA 212524 | TORRENT | 2025-01-13 | 3 |
| ANDA 217277 | ALKEM LABS LTD | 2025-01-14 | 3 |
| ANDA 216623 | ALEMBIC | 2025-04-16 | 2 |
| ANDA 219939 | ALEMBIC | 2025-07-25 | 6 |
Official labeling on DailyMed
- CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.] · version 16 · 2026-09-11
- CARBAMAZEPINE TABLET [ALEMBIC PHARMACEUTICALS INC.] · version 6 · 2026-09-02
- CARBAMAZEPINE TABLET [REMEDYREPACK INC.] · version 6 · 2026-08-31
- CARBAMAZEPINE TABLET [APOTEX CORP.] · version 21 · 2026-08-28
- CARBAMAZEPINE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] · version 1 · 2026-08-28
- CARBAMAZEPINE TABLET, EXTENDED RELEASE [NORTHSTAR RX LLC] · version 7 · 2026-08-27
- CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.] · version 41 · 2026-08-25
- CARBAMAZEPINE TABLET, EXTENDED RELEASE [ASCEND LABORATORIES, LLC] · version 8 · 2026-08-21
- CARBAMAZEPINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] · version 7 · 2026-08-21
- TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] · version 39 · 2026-08-21
- CARBAMAZEPINE TABLET, EXTENDED RELEASE [UMEDICA LABORATORIES USA INC.] · version 7 · 2026-08-13
- CARBAMAZEPINE TABLET [UMEDICA LABORATORIES USA INC.] · version 4 · 2026-08-13
Showing the 12 most recent of 79 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.