Mycamine
These highlights do not include all the information needed to use MYCAMINE safely and effectively. See full prescribing information for MYCAMINE. MYCAMINE (micafungin for injection), for intravenous useInitial U.S. Approval: 2005
Approved
Approval ID
a064c4a7-25ec-4a2c-afc2-703491a4a38b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 4, 2022
Manufacturers
FDA
Astellas Pharma US, Inc.
DUNS: 605764828
Products 2
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 Code0469-3250
Application NumberNDA021506
Product Classification
M
Marketing Category
C73594
G
Generic Name
Micafungin sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 23, 2020
FDA Product Classification
INGREDIENTS (4)
MICAFUNGIN SODIUMActive
Quantity: 10 mg in 1 mL
Code: IS1UP79R56
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Micafungin sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0469-3211
Application NumberNDA021506
Product Classification
M
Marketing Category
C73594
G
Generic Name
Micafungin sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 23, 2020
FDA Product Classification
INGREDIENTS (4)
MICAFUNGIN SODIUMActive
Quantity: 20 mg in 1 mL
Code: IS1UP79R56
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT