Quick answers
- What is Colistimethate sodium used for?
- The FDA-approved label (Coly-Mycin M, Par Health USA, LLC, June 8, 2026) says: “Coly-Mycin M Parenteral 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Colistimethate sodium have a boxed warning?
- No. None of the 6 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Colistimethate sodium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Colistimethate sodium been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started February 25, 2015 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Colistimethate sodium?
- 5 companies list prescription products of Colistimethate sodium in the FDA NDC Directory, including Xellia Pharmaceuticals USA LLC, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. and Par Health USA, LLC.
What Colistimethate sodium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Coly-Mycin M Parenteral 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. …
— FDA label: Coly-Mycin M, Par Health USA, LLC, effective June 8, 2026. Read the full label on DailyMed →
The FDA has 6 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 6 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, for solution · Injection, powder, lyophilized, for solution · Injection |
|---|---|
| Route | Intramuscular · Intravenous |
| Prescription products | 5 in the FDA NDC Directory |
| Brand names | Coly-Mycin M |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| colistimethate sodium 150 mg injection, powder, for solution | Generic | $15.49 per unit |
| colistimethate sodium 150 mg/2 mL injection, powder, lyophilized, for solution | Generic | $15.49 per unit |
| colistimethate sodium 150 mg/4 mL injection, powder, lyophilized, for solution | Generic | $15.49 per unit |
NADAC list of November 4, 2026; these prices took effect between May 20, 2026 and June 3, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Xellia Pharmaceuticals USA LLC2 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 product
- Par Health USA, LLC1 product
- Hikma Pharmaceuticals USA Inc.1 product
- Fresenius Kabi USA, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA050108 COLY-MYCIN M | Ph Health | June 4, 1970 | 26, latest July 3, 2025 2025: Labeling · 2017: Labeling · 2013: Labeling |
Generic approvals (3)
- ANDA065364Fresenius Kabi USA · April 17, 2008
- ANDA202359Avet Lifesciences · September 28, 2012
- ANDA205356Xellia Pharms Aps · May 29, 2015
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
February 25, 2015 · Class II · Terminated · D-0415-2015
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc. NDC 23155-193-31 — Heritage Pharmaceuticals, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1117522, 1117525 |
|---|---|
| SPL set ID of the quoted label | 6d6e13e2-dc33-4b7b-84d0-66146a57c552 |
| FDA labels (SPL) | 6 |
| FDA applications | NDA050108, 3 ANDA |
| Active ingredients (FDA) | COLISTIMETHATE SODIUM |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Coly-Mycin M, Par Health USA, LLC, effective June 8, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →