Mitomycin

Product NDC
71335-2927
11-digit product format
713352927
Labeler code
71335
Product ID
71335-2927_fbb00883-4ca9-4396-bf6d-f5f1a136c08f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mitomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Bryant Ranch Prepack
Application
ANDA202670
Marketing category
ANDA
Marketing start
2022-03-11
Substance
MITOMYCIN
Active strength
5 mg/10mL
Pharmacologic classes
Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
50SG953SK6MITOMYCIN50-07-7MITOMYCIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2927-1713352927011 VIAL in 1 CARTON (71335-2927-1) / 10 mL in 1 VIAL1 vial2025-11-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
MITOMYCIN FOR INJECTION USP, 5 mg/vial NOVAPLUS ®Bryant Ranch Prepack2025-11-11HUMAN PRESCRIPTION DRUG LABEL100