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
Approved
Approval ID
5e1a64c2-283a-51a7-e053-2991aa0af15f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2024
Manufacturers
FDA
Prasco Laboratories
DUNS: 065969375
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 Code66993-489
Application NumberNDA050682
Product Classification
M
Marketing Category
C73605
G
Generic Name
Dactinomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 18, 2024
FDA Product Classification
INGREDIENTS (2)
DACTINOMYCINActive
Quantity: 0.5 mg in 1 mL
Code: 1CC1JFE158
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT