BORTEZOMIB injection, powder, lyophilized, for solution

BORTEZOMIB by

Drug Labeling and Warnings

BORTEZOMIB by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited, Zydus Hospira Oncology Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1708-1

Bortezomib for Injection

3.5 mg/vial

For Intravenous or Subcutaneous Use

One Single-dose Vial

Rx only

NDC: 70771-1708-1

Bortezomib for Injection – Carton label

3.5 mg/vial

For Intravenous or Subcutaneous Use

Reconstitution Information

SUBCUTANEOUS INJECTION ONLY

0.9% NaCl

Add

1.4 mL

0.9% Sodium Chloride

To make

2.5 mg/mL

final concentration

INTRAVENOUS INJECTION ONLY

0.9% NaCl

Add

3.5 mL

0.9% Sodium Chloride

To make

1 mg/mL

final concentration

One Single-dose Vial

Rx only

Reconstitution Information – Inside Flap (All cartons)

SUBCUTANEOUS INJECTION ONLY

0.9% NaCl

Add

1.4 mL

0.9% Sodium Chloride

To make

2.5 mg/mL

final concentration

INTRAVENOUS INJECTION ONLY

0.9% NaCl

Add

3.5 mL

0.9% Sodium Chloride

To make

1 mg/mL

final concentration

INGREDIENTS AND APPEARANCE

BORTEZOMIB 
bortezomib injection, powder, lyophilized, for solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1708
Route of Administration	INTRAVENOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BORTEZOMIB (UNII: 69G8BD63PP) (BORTEZOMIB - UNII:69G8BD63PP)	BORTEZOMIB	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MANNITOL (UNII: 3OWL53L36A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1708-1	1 in 1 CARTON	05/02/2022
1		3.5 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA210204	05/02/2022

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Hospira Oncology Private Limited		676190889	ANALYSIS(70771-1708) , LABEL(70771-1708) , MANUFACTURE(70771-1708) , PACK(70771-1708)