dactinomycin
These highlights do not include all the information needed to use Dactinomycin for Injection safely and effectively. See full prescribing information for Dactinomycin for Injection. Dactinomycin for Injection for intravenous use Initial U.S. Approval: 1964 Rx Only
Approved
Approval ID
efe03d73-eb11-45ff-a3cb-09a540ed352f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 23, 2021
Manufacturers
FDA
XGen Pharmaceuticals DJB, Inc.
DUNS: 117380305
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dactinomycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code39822-2100
Application NumberANDA203999
Product Classification
M
Marketing Category
C73584
G
Generic Name
dactinomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 23, 2021
FDA Product Classification
INGREDIENTS (2)
DACTINOMYCINActive
Quantity: 0.5 mg in 1 mL
Code: 1CC1JFE158
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT