Active ingredient
Zidovudine
8 finished FDA listings contain Zidovudine as their only active ingredient; 11 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- ZIDOVUDINE
- Dosage forms
- Capsule, Injection, Solution, Solution, Syrup, Tablet, Tablet, Film Coated
- Routes
- Intravenous, Oral
- Manufacturers / labelers
- 4
- Strengths listed
- 10 mg/ml · 100 mg/1 · 300 mg/1
- Brand names in FDA listings
- Retrovir
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 11413
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 019655 | VIIV HLTHCARE | 1987-03-19 | 1 |
| NDA 019910 | VIIV HLTHCARE | 1989-09-28 | 1 |
| NDA 019951 | VIIV HLTHCARE | 1990-02-02 | 1 |
| ANDA 077268 | AUROBINDO | 2005-09-19 | 1 |
| ANDA 077267 | AUROBINDO | 2005-09-19 | 1 |
| ANDA 078128 | AUROBINDO PHARMA LTD | 2006-03-27 | 1 |
| ANDA 090092 | HETERO LABS LTD III | 2008-04-25 | 2 |
Official labeling on DailyMed
- ZIDOVUDINE TABLET [COUPLER LLC] · version 2 · 2026-01-21
- RETROVIR (ZIDOVUDINE) CAPSULE RETROVIR (ZIDOVUDINE) SOLUTION RETROVIR (ZIDOVUDINE) INJECTION, SOLUTION [VIIV HEALTHCARE COMPANY] · version 32 · 2025-09-25
- ZIDOVUDINE SYRUP [AUROBINDO PHARMA LIMITED] · version 22 · 2025-02-17
- ZIDOVUDINE CAPSULE [AUROBINDO PHARMA LIMITED] · version 19 · 2025-02-17
- ZIDOVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] · version 22 · 2024-01-30
- ZIDOVUDINE (ZIDOVUDINE) TABLET [CAMBER PHARMACEUTICALS, INC.] · version 5 · 2023-05-17
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.