CASPOFUNGIN ACETATE
These highlights do not include all the information needed to use CASPOFUNGIN ACETATE FOR INJECTION safely and effectively. See full prescribing information for CASPOFUNGIN ACETATE FOR INJECTION. CASPOFUNGIN ACETATE for injection, for intravenous use Initial U.S. Approval: 2001
Approved
Approval ID
2239b366-663a-43d9-9cc6-d4bacb058abc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 12, 2021
Manufacturers
FDA
UBI Pharma Inc.
DUNS: 658871159
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CASPOFUNGIN ACETATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72843-434
Application NumberANDA211263
Product Classification
M
Marketing Category
C73584
G
Generic Name
CASPOFUNGIN ACETATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 12, 2021
FDA Product Classification
INGREDIENTS (5)
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
MANNITOLInactive
Quantity: 2.4 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SUCROSEInactive
Quantity: 3.6 mg in 1 mL
Code: C151H8M554
Classification: IACT
CASPOFUNGIN ACETATEActive
Quantity: 5 mg in 1 mL
Code: VUW370O5QE
Classification: ACTIB
CASPOFUNGIN ACETATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72843-533
Application NumberANDA211263
Product Classification
M
Marketing Category
C73584
G
Generic Name
CASPOFUNGIN ACETATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 12, 2021
FDA Product Classification
INGREDIENTS (5)
MANNITOLInactive
Quantity: 3.3 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SUCROSEInactive
Quantity: 5 mg in 1 mL
Code: C151H8M554
Classification: IACT
CASPOFUNGIN ACETATEActive
Quantity: 7 mg in 1 mL
Code: VUW370O5QE
Classification: ACTIB