Bortezomib (Page 8 of 8)

Principal Display Panel

​NDC 72266-243-01

BORTEZOMIB (bortezomib) INJECTION

3.5 mg per 3.5 mL

(1 mg per mL)

FOR INTRAVENOUS USE ONLY

READY-to-use Vial

​SINGLE DOSE VIAL

DISCARD UNUSED PORTION

CAUTION: Hazardous Agent

Vial Label 3.5 mg/ 3.5 mL

Carton Label 3.5 mg/ 3.5 mL

​NDC 72266-244-01

BORTEZOMIB ​ ​(bortezomib) INJECTION

3.5 mg per 1.4 mL

(2.5 mg per mL)

FOR INTRAVENOUS USE ONLY

​Ready-to-use Vial

CAUTION: Hazardous Agent

Vial Label 3.5 mg/ 1.4 mL

Carton Label 3.5 mg/ 1.4 mL

BORTEZOMIB bortezomib injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72266-243 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BORTEZOMIB (BORTEZOMIB) BORTEZOMIB 1 mg

Inactive Ingredients Ingredient Name Strength MANNITOL 10 mg SODIUM ACETATE 0.82 mg DIMETHYL SULFOXIDE 20 mg HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72266-243-01 1 INJECTION in 1 VIAL, SINGLE-DOSE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA215331 08/23/2022

BORTEZOMIB bortezomib injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72266-244 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BORTEZOMIB (BORTEZOMIB) BORTEZOMIB 2.5 mg

Inactive Ingredients Ingredient Name Strength MANNITOL 25 mg SODIUM ACETATE 0.82 mg DIMETHYL SULFOXIDE 22 mg HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72266-244-01 1 INJECTION in 1 VIAL, SINGLE-DOSE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA215331 08/23/2022

Labeler — FOSUN PHARMA USA INC (080920998)

Establishment
Name	Address	ID/FEI	Operations
Gland Pharma Limited		918601238	manufacture (72266-243), manufacture (72266-244)

Revised: 08/2022 FOSUN PHARMA USA INC