Dacarbazine
Dacarbazine for Injection, USP
Approved
Approval ID
b6b97e41-5f15-498c-abfb-d8443ea4d216
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 20, 2022
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DACARBAZINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-128
Application NumberANDA075371
Product Classification
M
Marketing Category
C73584
G
Generic Name
DACARBAZINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 20, 2022
FDA Product Classification
INGREDIENTS (3)
CITRIC ACID MONOHYDRATEInactive
Quantity: 10 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
DACARBAZINEActive
Quantity: 10 mg in 1 mL
Code: 7GR28W0FJI
Classification: ACTIB
MANNITOLInactive
Quantity: 3.75 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
DACARBAZINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-127
Application NumberANDA075371
Product Classification
M
Marketing Category
C73584
G
Generic Name
DACARBAZINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 20, 2022
FDA Product Classification
INGREDIENTS (3)
CITRIC ACID MONOHYDRATEInactive
Quantity: 10 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
MANNITOLInactive
Quantity: 5 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
DACARBAZINEActive
Quantity: 10 mg in 1 mL
Code: 7GR28W0FJI
Classification: ACTIB