Micafungin
Micafungin for Injection, for intravenous use
Approved
Approval ID
72bc5dd6-6052-4483-9b13-afdeaaa8cc69
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 23, 2022
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
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 Code70771-1684
Application NumberANDA215241
Product Classification
M
Marketing Category
C73584
G
Generic Name
Micafungin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 23, 2022
FDA Product Classification
INGREDIENTS (4)
MICAFUNGIN SODIUMActive
Quantity: 20 mg in 1 mL
Code: IS1UP79R56
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Micafungin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1683
Application NumberANDA215241
Product Classification
M
Marketing Category
C73584
G
Generic Name
Micafungin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 23, 2022
FDA Product Classification
INGREDIENTS (4)
MICAFUNGIN SODIUMActive
Quantity: 10 mg in 1 mL
Code: IS1UP79R56
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT