Mitomycin
MITOMYCIN FOR INJECTION, USP
Approved
Approval ID
fde1e4e9-fc67-4e84-aa31-0cf0e73e19a8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 27, 2022
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mitomycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9136
Application NumberANDA064117
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mitomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 27, 2022
FDA Product Classification
INGREDIENTS (4)
MITOMYCINActive
Quantity: 40 mg in 1 1
Code: 50SG953SK6
Classification: ACTIB
MANNITOLInactive
Quantity: 80 mg in 1 1
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Mitomycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9135
Application NumberANDA064117
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mitomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 27, 2022
FDA Product Classification
INGREDIENTS (4)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MANNITOLInactive
Quantity: 40 mg in 1 1
Code: 3OWL53L36A
Classification: IACT
MITOMYCINActive
Quantity: 20 mg in 1 1
Code: 50SG953SK6
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT