Micafungin
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . ; for intravenous infusion onlyInitial U.S. Approval: 2005
Approved
Approval ID
e0f728eb-cb52-5629-e92a-e10260d7687e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 12, 2023
Manufacturers
FDA
Apotex Corp.
DUNS: 845263701
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Micafungin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-6119
Application NumberANDA208366
Product Classification
M
Marketing Category
C73584
G
Generic Name
Micafungin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 12, 2023
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MICAFUNGINActive
Quantity: 10 mg in 1 mL
Code: R10H71BSWG
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Micafungin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-6120
Application NumberANDA208366
Product Classification
M
Marketing Category
C73584
G
Generic Name
Micafungin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 12, 2023
FDA Product Classification
INGREDIENTS (5)
MICAFUNGINActive
Quantity: 20 mg in 1 mL
Code: R10H71BSWG
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT