Prescription medicine
Micafungin First approved as Mycamine
Micafungin (Mycamine) is a prescription medicine with an FDA approval on record since 2005. FDA's NDC Directory lists it from 10 generic labelers.
- Generic listed
- A presentation discontinued
Check it at the source: the micafungin FDA label on DailyMed (effective November 8, 2025, Sagent Pharmaceuticals); the NDA 21754 record on Drugs@FDA; every micafungin label on DailyMed.
Highlights of the record
FDA label of November 8, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageMicafungin 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 [see Clinical Studies ( 14.1 ) and Use in Specific Populations ( 8.4 )].
Forms and strengths
- 50 mg
- 100 mg
- 10 mg/ml
- 20 mg/ml
- 50 mg/5ml
- 50 mg/50ml
- 100 mg/5ml
- 100 mg/100ml
- 150 mg/150ml
Injection (powder) (lyophilized) for solution; injection; injection (powder) for solution.
On the market
- Earliest approval on file
- March 16, 2005 Mycamine, Fujisawa Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first May 17, 2019; 11 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 11 of which 10 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 15, 2037 Micafungin In Sodium Chloride 0.9% injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 2 past records
- Recalls by its makers (FDA)
- 4 since 2021 0 Class I among all firms' recalls; latest July 2, 2024
- FAERS reports
- 6,383 through July 30, 2026
What is micafungin used for?
From the label: indications and usageMicafungin 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 [see Clinical Studies ( 14.1 ) and Use in Specific Populations ( 8.4 )]. 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 [see Use in Specific Populations ( 8.4 )]. Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies ( 14.2 )]. […]
Conditions named in the indications of micafungin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Echinocandin Antifungal.
Source: FDA drug label (Micafungin), Sagent Pharmaceuticals, effective November 8, 2025 (SPL set 33e579c1-b315-44cb-a690-e2dd2cdf44ee), via openFDA; the full label on DailyMed
Is there a generic for micafungin (Mycamine)?
The FDA approved the first generic micafungin on May 17, 2019. 12 generic applications are approved; 11 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 micafungin from 10 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.
The Orange Book lists no patent for Mycamine injection; a patent listed only for Micafungin In Sodium Chloride 0.9% injection runs to December 15, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2005 earliest approval on file
- 2019 first generic approved
- 2037 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is micafungin in shortage?
No micafungin presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 2 records are all marked to be discontinued, the latest updated September 11, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Micafungin Sodium, Injection, 10 mg/1 mL (NDC 42023-229-10) | Par Health, USA LLC | To Be Discontinued | September 11, 2026 |
| Micafungin Sodium, Injection, 20 mg/1 mL (NDC 42023-230-10) | Par Health, USA LLC | To Be Discontinued | September 11, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has micafungin been recalled?
The FDA's Enforcement Report lists 4 recalls naming micafungin since 2021: 0 Class I (the most serious), 2 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 2, 2024 | Class III | Zydus Pharmaceuticals (USA) Inc | Cross contamination with other products |
| August 6, 2021 | Class II | XELLIA PHARMACEUTICALS USA, LLC | Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the micafungin label say about other medicines?
The micafungin label names 12 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Amphotericin b | drug interactions | Co-administration of Micafungin with Other Drugs Co-administration of micafungin with mycophenolate mofetil (MMF), amphotericin B, tacrolimus, prednisolone, sirolimus and nifedipine did not alter the pharmacokinetics of micafungin. |
| Cyclosporine | drug interactions | Drugs on Micafungin CYP3A4, CYP2C9 and CYP2C19 Inhibitors Co-administration of micafungin with cyclosporine, itraconazole, voriconazole and fluconazole did not alter the pharmacokinetics of micafungin. |
| Fluconazole | drug interactions | Drugs on Micafungin CYP3A4, CYP2C9 and CYP2C19 Inhibitors Co-administration of micafungin with cyclosporine, itraconazole, voriconazole and fluconazole did not alter the pharmacokinetics of micafungin. |
| Itraconazole | drug interactions | DRUG INTERACTIONS Monitor for sirolimus, itraconazole or nifedipine toxicity, and dosage of sirolimus, itraconazole or nifedipine should be reduced, if necessary. |
| Mycophenolate mofetil | drug interactions | Co-administration of Micafungin with Other Drugs Co-administration of micafungin with mycophenolate mofetil (MMF), amphotericin B, tacrolimus, prednisolone, sirolimus and nifedipine did not alter the pharmacokinetics of micafungin. |
| Nifedipine | drug interactions | DRUG INTERACTIONS Monitor for sirolimus, itraconazole or nifedipine toxicity, and dosage of sirolimus, itraconazole or nifedipine should be reduced, if necessary. |
| Prednisolone | drug interactions | Co-administration of Micafungin with Other Drugs Co-administration of micafungin with mycophenolate mofetil (MMF), amphotericin B, tacrolimus, prednisolone, sirolimus and nifedipine did not alter the pharmacokinetics of micafungin. |
| Rifampin | drug interactions | CYP2C19 and CYP3A4 Inducer Co-administration of micafungin with rifampin and ritonavir did not alter the pharmacokinetics of micafungin. |
| Ritonavir | drug interactions | CYP2C19 and CYP3A4 Inducer Co-administration of micafungin with rifampin and ritonavir did not alter the pharmacokinetics of micafungin. |
| Sirolimus | drug interactions | DRUG INTERACTIONS Monitor for sirolimus, itraconazole or nifedipine toxicity, and dosage of sirolimus, itraconazole or nifedipine should be reduced, if necessary. |
| Tacrolimus | drug interactions | Co-administration of Micafungin with Other Drugs Co-administration of micafungin with mycophenolate mofetil (MMF), amphotericin B, tacrolimus, prednisolone, sirolimus and nifedipine did not alter the pharmacokinetics of micafungin. |
| Voriconazole | drug interactions | Drugs on Micafungin CYP3A4, CYP2C9 and CYP2C19 Inhibitors Co-administration of micafungin with cyclosporine, itraconazole, voriconazole and fluconazole did not alter the pharmacokinetics of micafungin. |
Source: FDA drug label (Micafungin), Sagent Pharmaceuticals, effective November 8, 2025 (SPL set 33e579c1-b315-44cb-a690-e2dd2cdf44ee), via openFDA; the full label on DailyMed
What do FAERS reports show for micafungin?
The FDA Adverse Event Reporting System holds 6,383 reports that list micafungin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,365 are coded as a death and 3,096 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 else is labeled for the same conditions as micafungin?
6 other medicines are given the same way (intravenous) and in the same FDA class as micafungin or labeled mainly for the same use (fungal infections), the same class first. Fungal infections lists all 33 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Caspofungin | Fungal infections | 5 labelers | n/a | A presentation being discontinued |
| Anidulafungin | Fungal infections | none listed | n/a | No current entry |
| Voriconazole | Fungal infections | 12 labelers | n/a | A presentation being discontinued |
| Fluconazole | Fungal infections | 4 labelers | n/a | No current entry |
| Posaconazole | Fungal infections | 7 labelers | n/a | A presentation being discontinued |
| Amphotericin b | Fungal infections | 5 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as micafungin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does micafungin compare with medicines for the same use?
3 side-by-side pages set micafungin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to micafungin
- 6 medicines for the same use
- Other echinocandin antifungals
- the pharmacologic class, with prices and generics
- Micafungin side effects
- the label's list beside FAERS reports
- Micafungin shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other