Dactinomycin

Product NDC
67457-928
11-digit product format
674570928
Labeler code
67457
Product ID
67457-928_c350c9a1-e82c-40f3-a2f7-ae904294b6c4
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
2019-06-20
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-928-02EA - Each67457-92868a7804d-e867-49ff-95e0-cad48d91911d12019-07-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67457-928-02674570928021 VIAL, SINGLE-DOSE in 1 CARTON (67457-928-02) > 1 mL in 1 VIAL, SINGLE-DOSE2019-06-200000-00-00NoNoCurrent