Dactinomycin

Product NDC
67457-513
11-digit product format
674570513
Labeler code
67457
Product ID
67457-513_a671719a-9ce2-400d-9003-e83360e7edd4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dactinomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA203385
Marketing category
ANDA
Marketing start
2018-01-01
Marketing end
0000-00-00
Substance
DACTINOMYCIN
Active strength
1 mg/mL
Pharmacologic classes
Actinomycin [EPC],Nucleic Acid Synthesis Inhibitors [MoA],Protein Synthesis Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-513-05EA - Each67457-51364bdb666-35a1-4ddb-9155-a831e7f90f3b12018-02-20
67457-513-99EA - Each67457-5130b8a9de7-18ee-432b-bd09-72437863136712018-02-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67457-513-05674570513051 VIAL, SINGLE-DOSE in 1 CARTON (67457-513-05) > 1 mL in 1 VIAL, SINGLE-DOSE2018-01-010000-00-00NoNoCurrent