Micafungin
These highlights do not include all the information needed to use MICAFUNGIN FOR INJECTION safely and effectively. See full prescribing information for MICAFUNGIN FOR INJECTION. MICAFUNGIN for injection, for intravenous useInitial U.S. Approval: 2005
Approved
Approval ID
f8198836-4011-40b9-af25-466ae08727f8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2020
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Micafungin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-729
Application NumberANDA207344
Product Classification
M
Marketing Category
C73584
G
Generic Name
Micafungin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 30, 2020
FDA Product Classification
INGREDIENTS (4)
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Micafungin SodiumActive
Quantity: 100 mg in 1 1
Code: IS1UP79R56
Classification: ACTIB
Anhydrous Citric AcidInactive
Code: XF417D3PSL
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT