Mitomycin

Product NDC
67457-518
11-digit product format
674570518
Labeler code
67457
Product ID
67457-518_cecc31d9-bc8e-4d6f-b46c-4e3b3bea6307
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mitomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA202670
Marketing category
ANDA
Marketing start
2018-02-28
Marketing end
0000-00-00
Substance
MITOMYCIN
Active strength
5 mg/10mL
Pharmacologic classes
Alkylating Activity [MoA],Alkylating Drug [EPC]
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
67457-518-05EA - Each67457-51892f8b113-a2ee-423d-924a-71db83cd26df12018-04-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-518-05674570518051 VIAL in 1 CARTON (67457-518-05) > 10 mL in 1 VIAL1 vial2018-02-280000-00-00NoNoCurrent