Mitomycin

Product NDC
16729-246
11-digit product format
167290246
Labeler code
16729
Product ID
16729-246_aef282e1-cee2-406f-e053-2995a90a28af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mitomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Accord Healthcare Inc
Application
ANDA064144
Marketing category
ANDA
Marketing start
2013-05-03
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
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
16729-246-05EA - Each16729-2461dc6c19a-b7fc-4b69-b5f3-731b2ed65d0212013-11-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-246-05167290246051 VIAL in 1 CARTON (16729-246-05) > 10 mL in 1 VIAL1 vial2013-05-030000-00-00NoNoCurrent