MedPath

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

2aaca42a-3b79-4151-a727-83253556a540

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 13, 2020

Manufacturers
FDA

Meitheal Pharmaceuticals Inc.

DUNS: 080548348

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 Code71288-129
Application NumberANDA213463
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dactinomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 31, 2020
FDA Product Classification

INGREDIENTS (3)

waterInactive
Code: 059QF0KO0R
Classification: IACT
dactinomycinActive
Quantity: 0.5 mg in 1 mL
Code: 1CC1JFE158
Classification: ACTIB
mannitolInactive
Code: 3OWL53L36A
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Dactinomycin - FDA Drug Approval Details