Active ingredient
Bleomycin
12 finished FDA listings contain Bleomycin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- BLEOMYCIN, BLEOMYCIN SULFATE
- Dosage forms
- Injection, Powder, Lyophilized, For Solution, Powder, For Solution
- Routes
- Intramuscular, Intrapleural, Intravenous, Subcutaneous
- Manufacturers / labelers
- 5
- Strengths listed
- 15 [usp'u]/1 · 30 [usp'u]/1
- Brand names in FDA listings
- Bleomycin
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1622
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 |
|---|---|---|---|
| ANDA 065031 | HOSPIRA | 2000-03-10 | 4 |
| ANDA 065042 | HIKMA | 2001-10-17 | 2 |
| ANDA 065185 | FRESENIUS KABI USA | 2008-01-28 | 2 |
| ANDA 205030 | MEITHEAL | 2018-04-20 | 4 |
Official labeling on DailyMed
- BLEOMYCIN (BLEOMYCIN SULFATE) POWDER, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] · version 3 · 2026-04-22
- BLEOMYCIN POWDER, FOR SOLUTION [NORTHSTAR RX LLC] · version 5 · 2026-04-22
- BLEOMYCIN (BLEOMYCIN SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] · version 7 · 2024-10-14
- BLEOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 6 · 2024-04-15
- BLEOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] · version 20 · 2022-08-29
- BLEOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] · version 10 · 2022-08-29
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.