Active ingredient
Pyrazinamide
5 finished FDA listings contain Pyrazinamide as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PYRAZINAMIDE
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 5
- Strengths listed
- 500 mg/1
- Brand names in FDA listings
- Pyrazinamide
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 8987
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 080157 | NOVITIUM PHARMA | 1971-06-03 | 3 |
| ANDA 081319 | HIKMA | 1992-06-30 | 1 |
| ANDA 212541 | MACLEODS PHARMS | 2020-07-27 | 1 |
Official labeling on DailyMed
- PYRAZINAMIDE TABLET [ANI PHARMACEUTICALS, INC.] · version 2 · 2026-03-03
- PYRAZINAMIDE (PYRAZINAMIDE TABLET) TABLET [MARLEX PHARMACEUTICALS, INC] · version 5 · 2026-01-14
- PYRAZINAMIDE TABLET [AMERICAN HEALTH PACKAGING] · version 2 · 2025-11-18
- PYRAZINAMIDE TABLET [HIKMA PHARMACEUTICALS USA INC] · version 2 · 2024-09-27
- PYRAZINAMIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED] · version 2 · 2023-01-02
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.