Active ingredient
Polymyxin B
10 finished FDA listings contain Polymyxin B as their only active ingredient; 378 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- POLYMYXIN B, POLYMYXIN B SULFATE
- Dosage forms
- Injection, Powder, For Solution, Injection, Powder, Lyophilized, For Solution
- Routes
- Intramuscular, Intrathecal, Intravenous, Ophthalmic
- Manufacturers / labelers
- 7
- Strengths listed
- 500000 [iu]/1 · 500000 [usp'u]/1
- Brand names in FDA listings
- Polymyxin B
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 8536
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 060716 | HIKMA | 1964-06-29 | 1 |
| ANDA 065372 | FRESENIUS KABI USA | 2008-01-10 | 2 |
| ANDA 202766 | XELLIA PHARMS APS | 2014-01-15 | 3 |
| ANDA 206589 | EUGIA PHARMA | 2016-04-04 | 1 |
| ANDA 207322 | GLAND | 2016-04-14 | 3 |
Official labeling on DailyMed
- POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC] · version 13 · 2026-06-24
- POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 13 · 2026-02-24
- POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] · version 1 · 2025-10-06
- POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FOSUN PHARMA USA INC] · version 4 · 2025-09-29
- POLYMYXIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC] · version 7 · 2025-05-15
- POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] · version 9 · 2025-05-14
- POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] · version 2 · 2022-12-12
- POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 3 · 2022-04-29
- POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC · version 1 · 2021-06-10
- POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC · version 4 · 2021-03-19
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.