Prescription medicine
Colistimethate Brand names: Coly-Mycin; first approved as Coly-Mycin M
Colistimethate (Coly-Mycin) is a prescription medicine with an FDA approval on record since 1970. FDA's NDC Directory lists it from 4 generic labelers, and pharmacies paid $15.49 per colistimethate 150 mg vial in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the colistimethate FDA label on DailyMed (effective January 12, 2026, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.); the NDA 50108 record on Drugs@FDA; every colistimethate label on DailyMed.
Highlights of the record
FDA label of January 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageColistimethate for Injection, USP is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli.
Forms and strengths
- 150 mg
- 150 mg/2ml
- 150 mg/4ml
Injection (powder) for solution; injection (powder) (lyophilized) for solution; injection.
On the market
- Earliest approval on file
- June 4, 1970 Coly-Mycin M, Ph Health; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first February 26, 1999; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 4 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $15.49 per vial Colistimethate 150 mg vial
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2015 0 Class I among all firms' recalls; latest February 25, 2015
- FAERS reports
- 1,645 through July 30, 2026
What is colistimethate used for?
From the label: indications and usageColistimethate for Injection, USP is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa. This antibiotic is not indicated for infections due to Proteus or Neisseria. Colistimethate for Injection, USP has proven clinically effective in treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa. […]
Conditions named in the indications of colistimethate's FDA labels, with every medicine labeled for each:
From other colistimethate labelsBacterial infections: Colistimethate for Injection, USP may be used to initiate therapy in serious infections that are suspected to be due to gram-negative organisms and in the treatment of infections due to susceptible gram-negative pathogenic bacilli.
FDA pharmacologic class: Polymyxin-class Antibacterial.
Source: FDA drug label (COLISTIMETHATE SODIUM), Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effective January 12, 2026 (SPL set 6a335659-03b0-4a2d-9cd4-7dcf7da96fe6), via openFDA; the full label on DailyMed
Is there a generic for colistimethate (Coly-Mycin)?
The FDA approved the first generic colistimethate on February 26, 1999. 6 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists colistimethate from 4 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1970 earliest approval on file
- 1999 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for colistimethate (Coly-Mycin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $15.49 per Colistimethate 150 mg vial. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Colistimethate 150 mg vial (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Colistimethate 150 mg vial | Generic | $15.49 per vial | n/a | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has colistimethate been recalled?
The FDA's Enforcement Report lists 1 recall naming colistimethate since 2015: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 25, 2015 | Class II | Heritage Pharmaceuticals, Inc. | Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the colistimethate label say about other medicines?
The colistimethate label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 5 other medicines name colistimethate. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Succinylcholine | drug interactions | Curariform muscle relaxants (e.g., tubocurarine) and other drugs, including ether, succinylcholine, gallamine, decamethonium and sodium citrate, potentiate the neuromuscular blocking effect and should be used with extreme caution in patients being treated with Colistimethate for Injection, USP. |
Source: FDA drug label (COLISTIMETHATE SODIUM), Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effective January 12, 2026 (SPL set 6a335659-03b0-4a2d-9cd4-7dcf7da96fe6), via openFDA; the full label on DailyMed
What do FAERS reports show for colistimethate?
The FDA Adverse Event Reporting System holds 1,645 reports that list colistimethate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 214 are coded as a death and 904 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other polymyxin-class antibacterials
- the pharmacologic class, with prices and generics
- Colistimethate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other