Active ingredient
Oxazepam
13 finished FDA listings contain Oxazepam as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- OXAZEPAM
- Dosage forms
- Capsule, Capsule, Gelatin Coated
- Routes
- Oral
- Manufacturers / labelers
- 5
- Strengths listed
- 10 mg/1 · 15 mg/1 · 30 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 7781
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 071026 | TP ANDA HOLDINGS | 1987-08-10 | 4 |
| ANDA 072253 | ACTAVIS ELIZABETH | 1988-04-14 | 6 |
| ANDA 218261 | LEADING | 2025-03-03 | 3 |
Official labeling on DailyMed
- OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.] · version 20 · 2025-11-17
- OXAZEPAM CAPSULE [LEADING PHARMA, LLC] · version 3 · 2025-07-18
- OXAZEPAM CAPSULE [TRUPHARMA, LLC] · version 9 · 2025-01-02
- OXAZEPAM CAPSULE, GELATIN COATED [AMERICAN HEALTH PACKAGING] · version 12 · 2024-11-18
- OXAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] · version 1 · 2022-03-11
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.