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
33e579c1-b315-44cb-a690-e2dd2cdf44ee
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 4, 2022
Manufacturers
FDA
Sagent Pharmaceuticals
DUNS: 796852890
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 Code25021-190
Application NumberANDA213363
Product Classification
M
Marketing Category
C73584
G
Generic Name
Micafungin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 4, 2022
FDA Product Classification
INGREDIENTS (5)
anhydrous citric acidInactive
Code: XF417D3PSL
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Micafungin SodiumActive
Quantity: 50 mg in 5 mL
Code: IS1UP79R56
Classification: ACTIB
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
Micafungin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25021-191
Application NumberANDA213363
Product Classification
M
Marketing Category
C73584
G
Generic Name
Micafungin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 4, 2022
FDA Product Classification
INGREDIENTS (5)
anhydrous citric acidInactive
Code: XF417D3PSL
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Micafungin SodiumActive
Quantity: 100 mg in 5 mL
Code: IS1UP79R56
Classification: ACTIB
waterInactive
Code: 059QF0KO0R
Classification: IACT