Quick answers
- What is Micafungin used for?
- The FDA-approved label (Micafungin, Hisun Pharmaceuticals USA, Inc., April 14, 2026) says: “Micafungin for Injection is indicated for: Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older […]. Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Micafungin have a boxed warning?
- No. None of the 11 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Micafungin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Micafungin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Micafungin?
- 11 companies list prescription products of Micafungin in the FDA NDC Directory, including Fresenius Kabi USA, LLC, Baxter Healthcare Corporation and Sagent Pharmaceuticals.
What Micafungin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Micafungin for Injection is indicated for: Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older […]. Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age […]. …
— FDA label: Micafungin, Hisun Pharmaceuticals USA, Inc., effective April 14, 2026. Read the full label on DailyMed →
The FDA has 11 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 11 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution · Injection · Injection, powder, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 23 in the FDA NDC Directory |
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.
- Fresenius Kabi USA, LLC3 products
- Baxter Healthcare Corporation3 products
- Sagent Pharmaceuticals2 products
- Zydus Lifesciences Limited2 products
- Zydus Pharmaceuticals USA Inc.2 products
- Biocon Pharma Inc.2 products
- Meitheal Pharmaceuticals Inc.2 products
- Hisun Pharmaceuticals USA, Inc.2 products
- Qilu Pharmaceutical Co., Ltd.2 products
- Hikma Pharmaceuticals USA Inc.2 products
- Glenmark Pharmaceuticals Inc., USA2 products
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 |
|---|---|---|---|
| NDA216142 MICAFUNGIN IN SODIUM CHLORIDE 0.9% | Baxter Hlthcare Corp | September 29, 2023 | — |
Generic approvals (8)
- ANDA207344Fresenius Kabi USA · May 17, 2019
- ANDA213261Hikma · July 9, 2021
- ANDA213363Jiangsu Hansoh Pharm · July 9, 2021
- ANDA215381Meitheal · September 28, 2022
- ANDA215241Zydus Pharms · October 24, 2022
- ANDA216438Biocon Pharma · May 29, 2024
- ANDA219273Qilu Pharm Hainan · April 3, 2025
- ANDA219712Hisun Pharm Hangzhou · January 21, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 861379, 861383 |
|---|---|
| SPL set ID of the quoted label | 230fcff4-ad4b-ea25-e063-6394a90a1fab |
| FDA labels (SPL) | 11 |
| FDA applications | NDA216142, 8 ANDA |
| Active ingredients (FDA) | MICAFUNGIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Micafungin, Hisun Pharmaceuticals USA, Inc., effective April 14, 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 →