Active ingredient
Rifabutin
7 finished FDA listings contain Rifabutin as their only active ingredient; 1 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- RIFABUTIN
- Dosage forms
- Capsule
- Routes
- Oral
- Manufacturers / labelers
- 6
- Strengths listed
- 150 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 55672
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 050689 | PFIZER | 1992-12-23 | 2 |
| ANDA 215041 | NOVITIUM PHARMA | 2021-12-17 | 3 |
| ANDA 212430 | PHARMAZONE | 2026-03-19 | 2 |
Official labeling on DailyMed
- RIFABUTIN CAPSULE [REMEDYREPACK INC.] · version 7 · 2026-09-02
- RIFABUTIN CAPSULE [MYLAN PHARMACEUTICALS INC.] · version 14 · 2026-07-22
- RIFABUTIN CAPSULE [REMEDYREPACK INC.] · version 2 · 2026-06-08
- RIFABUTIN CAPSULE [A2A INTEGRATED PHARMACEUTICALS] · version 1 · 2026-06-01
- RIFABUTIN CAPSULE [I3 PHARMACEUTICALS, LLC] · version 6 · 2026-04-17
- RIFABUTIN CAPSULE [MARLEX PHARMACEUTICALS, INC.] · version 4 · 2025-11-19
- RIFABUTIN CAPSULE [ANI PHARMACEUTICALS, INC.] · version 2 · 2025-04-10
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.