Quick answers
- What is Amikacin used for?
- The FDA-approved label (Arikayce, Insmed Incorporated, August 4, 2026) says: “LIMITED POPULATION: ARIKAYCE ® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Amikacin have a boxed warning?
- Yes. The FDA label for Arikayce has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Amikacin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Amikacin been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started May 21, 2019 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Amikacin?
- 7 companies list prescription products of Amikacin in the FDA NDC Directory, including Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Hikma Pharmaceuticals USA Inc. and Mullan Pharmaceutical Inc..
What Amikacin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LIMITED POPULATION: ARIKAYCE ® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. …
— FDA label: Arikayce, Insmed Incorporated, effective August 4, 2026. Read the full label on DailyMed →
The FDA has 8 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.
This label has a boxed warning. Read it on the full label →
8 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection · Suspension |
|---|---|
| Route | Intramuscular · Intravenous · Respiratory (inhalation) |
| Prescription products | 12 in the FDA NDC Directory |
| Brand names | Arikayce |
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 |
|---|---|---|
| amikacin sulfate 250 mg/mL injection | Generic | $2.43 per mL |
| amikacin sulfate 250 mg/mL injection, solution | Generic | $2.43 per mL |
| amikacin sulfate 500 mg/2 mL injection, solution | Generic | $2.43 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 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.
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.3 products
- Hikma Pharmaceuticals USA Inc.2 products
- Mullan Pharmaceutical Inc.2 products
- Qilu Pharmaceutical Co., Ltd.2 products
- Sagent Pharmaceuticals1 product
- Fresenius Kabi USA, LLC1 product
- Insmed Incorporated1 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 |
|---|---|---|---|
| NDA207356 ARIKAYCE KIT | Insmed Inc | September 28, 2018 | 6, latest June 25, 2026 2026: Labeling · 2025: Labeling · 2023: Labeling |
Generic approvals (5)
- ANDA063315Hikma · April 11, 1994
- ANDA204040Avet Lifesciences · December 12, 2013
- ANDA205604Fresenius Kabi USA · December 9, 2015
- ANDA203323Sagent Pharms Inc · May 12, 2016
- ANDA218146Qilu · March 19, 2024
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.
-
May 21, 2019 · Class I · Terminated · D-1398-2019
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only, Mfd. by: Emcure Pharmaceuticals, Ltd., Hinjawadi, Pune, India Mfd. for: Heritage Pharmaceuticals Inc.. NDC 23155-290-32 — 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) | 1723156, 1723160, 2059184, 2059189 |
|---|---|
| SPL set ID of the quoted label | 499ab990-2b21-474f-aaba-d86388965f40 |
| FDA labels (SPL) | 8 |
| FDA applications | NDA207356, 5 ANDA |
| Active ingredients (FDA) | AMIKACIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Arikayce, Insmed Incorporated, effective August 4, 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 →