NDC Code(s) : 60505-6228-0
Packager : Apotex Corp

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bendamustine HydrochlorideBendamustine Hydrochloride INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-6228
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENDAMUSTINE HYDROCHLORIDE(UNII: 981Y8SX18M)
(Bendamustine - UNII:9266D9P3PQ) 		BENDAMUSTINE HYDROCHLORIDE25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MONOTHIOGLYCEROL(UNII: AAO1P0WSXJ)5 mg in 1 mL
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SODIUM HYDROXIDE (UNII: 55X04QC32I)0.08 mg in 1 mL
ALCOHOL(UNII: 3K9958V90M)38 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60505-6228-01 in 1 CARTON 26/04/2023
15 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA215033 04/26/2023

LABELER - Apotex Corp(845263701)

REGISTRANT - Apotex Inc(209429182)

PRINCIPAL DISPLAY PANEL

ctn-label-100mg