Active ingredient
Chlordiazepoxide
28 finished FDA listings contain Chlordiazepoxide as their only active ingredient; 20 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- CHLORDIAZEPOXIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE
- Dosage forms
- Capsule, Capsule, Gelatin Coated
- Routes
- Oral
- Manufacturers / labelers
- 15
- Strengths listed
- 10 mg/1 · 25 mg/1 · 5 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2356
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 084768 | BARR | 1976-06-10 | 2 |
| ANDA 083116 | BARR | 1976-06-10 | 6 |
| ANDA 084769 | BARR | 1976-06-10 | 12 |
| ANDA 084041 | CHARTWELL RX | 1976-06-15 | 1 |
| ANDA 084678 | CHARTWELL RX | 1976-06-15 | 1 |
| ANDA 084679 | CHARTWELL RX | 1976-06-15 | 1 |
| ANDA 085461 | BAUSCH | 1977-09-21 | 1 |
| ANDA 085472 | BAUSCH | 1977-09-21 | 2 |
| ANDA 085475 | BAUSCH | 1977-09-21 | 2 |
Official labeling on DailyMed
- CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.] · version 14 · 2026-07-13
- CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.] · version 20 · 2026-06-24
- CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [COUPLER LLC] · version 1 · 2026-06-23
- CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [UNIT DOSE SOLUTIONS, INC.] · version 1 · 2026-06-22
- CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [COUPER LLC] · version 1 · 2026-05-07
- CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [SAFECOR HEALTH, LLC] · version 2 · 2026-04-09
- CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [CHARTWELL RX, LLC] · version 7 · 2025-12-11
- CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.] · version 19 · 2025-11-17
- CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] · version 19 · 2025-09-17
- CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK] · version 101 · 2025-08-21
- CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA, INC.] · version 16 · 2025-06-30
- CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS,INC.] · version 3 · 2024-07-19
Showing the 12 most recent of 16 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.