Active ingredient
Pyrimethamine
6 finished FDA listings contain Pyrimethamine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PYRIMETHAMINE
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 6
- Strengths listed
- 25 mg/1
- Brand names in FDA listings
- Daraprim
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 9010
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 008578 | TILDE SCIENCES | 1953-01-23 | 3 |
| ANDA 207127 | SANALUZ | 2020-02-28 | 1 |
| ANDA 215506 | TEVA PHARMS | 2021-08-13 | 1 |
| ANDA 216983 | AUROBINDO PHARMA LTD | 2022-10-25 | 1 |
Official labeling on DailyMed
- PYRIMETHAMINE TABLET [TEVA PHARMACEUTICALS, INC.] · version 3 · 2026-08-20
- PYRIMETHAMINE TABLET [AUROBINDO PHARMA LIMITED] · version 2 · 2024-01-22
- DARAPRIM (PYRIMETHAMINE) TABLET [TILDE SCIENCES LLC] · version 1 · 2023-12-11
- PYRIMETHAMINE TABLET [DR.REDDYS LABORATORIES INC] · version 7 · 2023-07-11
- DARAPRIM (PYRIMETHAMINE) TABLET [VYERA PHARMACEUTICALS LLC] · version 8 · 2021-12-02
- PYRIMETHAMINE TABLET [OAKRUM PHARMA, LLC] · version 4 · 2021-12-01
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.