NDC Code(s) : 42367-521-25
Packager : Eagle Pharmaceuticals, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BELRAPZObendamustine hydrochloride INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42367-521
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENDAMUSTINE HYDROCHLORIDE(UNII: 981Y8SX18M)
(BENDAMUSTINE - UNII:9266D9P3PQ) 		BENDAMUSTINE HYDROCHLORIDE100 mg
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
MONOTHIOGLYCEROL(UNII: AAO1P0WSXJ)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Product Characteristics
Color YELLOW (colorless to yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42367-521-251 in 1 CARTON 06/03/2019
11 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 NDA205580 06/03/2019

LABELER - Eagle Pharmaceuticals, Inc(849818161)

PRINCIPAL DISPLAY PANEL

Carton Label



PRINCIPAL DISPLAY PANEL

Vial Label (Front)



PRINCIPAL DISPLAY PANEL

Vial Label (Inside of Front Label)



PRINCIPAL DISPLAY PANEL

Carton Label