NDC Code(s) : 0173-0896-01
Packager : GlaxoSmithKline LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BlenrepBelantamab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0896
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BELANTAMAB MAFODOTIN(UNII: DB1041CXDG)
(BELANTAMAB MAFODOTIN - UNII:DB1041CXDG) 		BELANTAMAB MAFODOTIN50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
EDETATE DISODIUM(UNII: 7FLD91C86K)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TREHALOSE DIHYDRATE(UNII: 7YIN7J07X4)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0173-0896-011 in 1 CARTON 08/05/2020
12 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761158 08/05/2020 06/30/2024

LABELER - GlaxoSmithKline LLC(167380711)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 0173-0896-01

BLENREP

(belantamab mafodotin-blmf)

for injection

100 mg/vial

CAUTION: Hazardous Agent.

For intravenous infusion after reconstitution and dilution.

Single-dose vial.

Discard unused portion.

No preservative.

No U.S. standard of potency.

Dispense the enclosed Medication Guide to each patient.

©2020 GSK group of companies or its licensor.

Rev. 8/20

62000000041460

Blenrep carton