Label: BORTEZOMIB injection, powder, lyophilized, for solution
- NDC Code(s): 70771-1708-1
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 5, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Bortezomib for Injection
3.5 mg/vial
For Intravenous or Subcutaneous Use
One Single-dose Vial
Rx only
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
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INGREDIENTS AND APPEARANCE
BORTEZOMIB
bortezomib injection, powder, lyophilized, for solutionProduct 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)