Active ingredient
Propylthiouracil
8 finished FDA listings contain Propylthiouracil as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PROPYLTHIOURACIL
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 7
- Strengths listed
- 50 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 8794
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 006188 | PH HEALTH | 1947-07-28 | 2 |
| ANDA 080016 | CHARTWELL MOLECULAR | 1970-07-24 | 1 |
| ANDA 080154 | QUAGEN | 1971-07-23 | 3 |
| ANDA 080172 | ACTAVIS ELIZABETH | 1973-01-09 | 1 |
| ANDA 208867 | MACLEODS PHARMS | 2023-05-10 | 1 |
Official labeling on DailyMed
- PROPYLTHIOURACIL TABLET [PAR HEALTH USA, LLC] · version 18 · 2026-09-10
- PROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING] · version 7 · 2026-08-31
- PROPYLTHIOURACIL TABLET [TEVA PHARMACEUTICALS, INC.] · version 4 · 2025-11-17
- PROPYLTHIOURACIL TABLET [BRYANT RANCH PREPACK] · version 100 · 2025-11-17
- PROPYLTHIOURACIL TABLET [MACLEODS PHARMACEUTICALS LIMITED] · version 2 · 2024-09-23
- PROPYLTHIOURACIL TABLET [BRYANT RANCH PREPACK] · version 102 · 2024-08-21
- PROPYLTHIOURACIL TABLET [CHARTWELL RX, LLC] · version 1 · 2023-12-27
- PROPYLTHIOURACIL TABLET [QUAGEN PHARMACEUTICALS LLC] · version 2 · 2023-02-17
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.