Active ingredient
Clorazepate
25 finished FDA listings contain Clorazepate as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CLORAZEPATE DIPOTASSIUM
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 8
- Strengths listed
- 15 mg/1 · 15 mg/mg · 3.75 mg/1 · 3.75 mg/mg · 7.5 mg/1 · 7.5 mg/mg
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2353
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 |
|---|---|---|---|
| ANDA 071858 | AUROBINDO PHARMA | 1987-07-17 | 6 |
| ANDA 075731 | TARO | 2000-04-27 | 12 |
| ANDA 215566 | COREPHARMA | 2022-06-14 | 3 |
| ANDA 213730 | NOVITIUM PHARMA | 2022-06-16 | 4 |
Official labeling on DailyMed
- CLORAZEPATE DIPOTASSIUM TABLET [APOTEX CORP.] · version 5 · 2026-09-11
- CLORAZEPATE DIPOTASSIUM TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC] · version 1 · 2026-07-27
- CLORAZEPATE DIPOTASSIUM TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 8 · 2026-07-15
- CLORAZEPATE DIPOTASSIUM TABLET [AUROLIFE PHARMA LLC] · version 5 · 2026-03-26
- CLORAZEPATE DIPOTASSIUM TABLET [COUPLER LLC] · version 1 · 2025-10-02
- CLORAZEPATE DIPOTASSIUM TABLET [ANI PHARMACEUTICALS, INC.] · version 13 · 2025-08-14
- CLORAZEPATE DIPOTASSIUM TABLET [COUPLER LLC] · version 1 · 2025-02-06
- CLORAZEPATE DIPOTASSIUM TABLET [COUPLER LLC] · version 1 · 2025-01-30
- CLORAZEPATE DIPOTASSIUM TABLET [NORTHSTAR RX LLC] · version 4 · 2024-10-30
- CLORAZEPATE DIPOTASSIUM TABLET [AUROLIFE PHARMA LLC] · version 1 · 2024-01-23
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.