Active ingredient
Colistin
6 finished FDA listings contain Colistin as their only active ingredient; 1 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- COLISTIMETHATE SODIUM, COLISTIN SULFATE
- Dosage forms
- Injection, Injection, Powder, For Solution, Injection, Powder, Lyophilized, For Solution
- Routes
- Intramuscular, Intravenous
- Manufacturers / labelers
- 5
- Strengths listed
- 150 mg/1 · 150 mg/2ml · 150 mg/4ml
- Brand names in FDA listings
- Colistimethate, Coly-Mycin M
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2709
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 050108 | PH HEALTH | 1970-06-04 | 1 |
| ANDA 065364 | FRESENIUS KABI USA | 2008-04-17 | 1 |
| ANDA 202359 | AVET LIFESCIENCES | 2012-09-28 | 1 |
| ANDA 205356 | XELLIA PHARMS APS | 2015-05-29 | 3 |
Official labeling on DailyMed
- COLY-MYCIN M (COLISTIMETHATE) INJECTION [PAR HEALTH USA, LLC] · version 27 · 2026-06-22
- COLISTIMETHATE (COLISTIMETHATE SODIUM) INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC] · version 5 · 2026-04-09
- COLISTIMETHATE (COLISTIMETHATE SODIUM) INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 7 · 2026-03-09
- COLISTIMETHATE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] · version 18 · 2026-01-26
- COLISTIMETHATE (COLISTIMETHATE SODIUM) INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC] · version 3 · 2024-09-02
- COLISTIMETHATE (COLISTIMETHATE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] · version 5 · 2020-04-30
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.