Active ingredient
Niraparib
3 finished FDA listings contain Niraparib as their only active ingredient; 2 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- NIRAPARIB, NIRAPARIB TOSYLATE, NIRAPARIB TOSYLATE MONOHYDRATE
- Dosage forms
- Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 100 mg/1 · 200 mg/1 · 300 mg/1
- Brand names in FDA listings
- Zejula
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1918231
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 214876 | GLAXOSMITHKLINE | 2023-04-26 | 3 |
Official labeling on DailyMed
- ZEJULA (NIRAPARIB) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] · version 10 · 2026-08-06
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.