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Active ingredient

Micafungin

25 finished FDA listings contain Micafungin as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
MICAFUNGIN, MICAFUNGIN SODIUM
Dosage forms
Injection, Injection, Powder, For Solution, Injection, Powder, Lyophilized, For Solution
Routes
Intravenous
Manufacturers / labelers
12
Strengths listed
10 mg/ml · 100 mg/1 · 100 mg/100ml · 100 mg/5ml · 150 mg/150ml · 20 mg/ml · 50 mg/1 · 50 mg/50ml · 50 mg/5ml
Brand names in FDA listings
Micafungin, Mycamine

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 325887

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 021506ASTELLAS2005-03-161
ANDA 207344FRESENIUS KABI USA2019-05-173
ANDA 213261HIKMA2021-07-092
ANDA 213363JIANGSU HANSOH PHARM2021-07-092
ANDA 215381MEITHEAL2022-09-282
ANDA 215241ZYDUS PHARMS2022-10-244
NDA 216142BAXTER HLTHCARE CORP2023-09-293
ANDA 216438BIOCON PHARMA2024-05-292
ANDA 219273QILU PHARM HAINAN2025-04-034
ANDA 219712HISUN PHARM HANGZHOU2026-01-212

Official labeling on DailyMed

Showing the 12 most recent of 13 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.