Active ingredient
Primaquine
5 finished FDA listings contain Primaquine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PRIMAQUINE PHOSPHATE
- Dosage forms
- Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 5
- Strengths listed
- 15 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 8687
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 008316 | SANOFI AVENTIS US | 1952-01-23 | 1 |
| ANDA 204476 | UNICHEM | 2014-02-25 | 2 |
| ANDA 206043 | INGENUS PHARMS LLC | 2016-06-23 | 2 |
Official labeling on DailyMed
- PRIMAQUINE PHOSPHATE TABLET [PD-RX PHARMACEUTICALS, INC.] · version 12 · 2026-05-13
- PRIMAQUINE PHOSPHATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] · version 9 · 2026-03-02
- PRIMAQUINE PHOSPHATE TABLET, FILM COATED [AVKARE] · version 5 · 2026-02-26
- PRIMAQUINE PHOSPHATE TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC] · version 20 · 2026-02-23
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.