NDC Code(s) : 63459-348-04
Packager : Teva Pharmaceuticals USA, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bendekabendamustine hydrochloride INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63459-348
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
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
MONOTHIOGLYCEROL(UNII: AAO1P0WSXJ)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63459-348-041 in 1 CARTON 12/08/2015
14 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 NDA208194 12/08/2015

LABELER - Teva Pharmaceuticals USA, Inc.(183236314)

PRINCIPAL DISPLAY PANEL

NDC 63459-348-04
Sterile

Rx Only
Multi-Dose Vial

BENDEKA™
(bendamustine HCl) Injection

100 mg/4 mL
(25 mg/mL)

For Intravenous Infusion Only

Must be diluted prior to administration.

Distributed By:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Product of India
GUJ/DRUGS/G/28/1304

Carton Label

PRINCIPAL DISPLAY PANEL

NDC 63459-348-04
Sterile

Multi-Dose Vial
Rx Only

BENDEKA™
(bendamustine HCl) Injection

100 mg/4 mL
(25 mg/mL)

Must be diluted prior to administration.

For Intravenous Infusion Only

Store in refrigerator, 2° to 8°C (36° to 46 °F). Retain in original carton until time of use to protect from light. See package insert for dosing and dilution information.

Distributed By:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Product of India
GUJ/DRUGS/G/28/1304

Vial Label

PRINCIPAL DISPLAY PANEL

NDC 63459-348-04
Sterile

Rx Only
Multi-Dose Vial

BENDEKA™
(bendamustine HCl) Injection

100 mg/4 mL
(25 mg/mL)

For Intravenous Infusion Only

Must be diluted prior to administration.

Distributed By:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Product of Italy

Alternate Carton Label

PRINCIPAL DISPLAY PANEL

NDC 63459-348-04
Sterile

Multi-Dose Vial
Rx Only

BENDEKA™
(bendamustine HCl) Injection

100 mg/4 mL
(25 mg/mL)

Must be diluted prior to administration.

For Intravenous Infusion Only

Store in refrigerator, 2° to 8°C (36° to 46 °F). Retain in original carton until time of use to protect from light. See package insert for dosing and dilution information.

Distributed By:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Product of Italy

Alternate Vial Label