Bebtelovimab: Package Insert and Label Information (Page 5 of 5)


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PACKAGE LABEL — Bebtelovimab Injection 175 mg/2 mL (87.5 mg/mL) Vial Carton

NDC 0002-7589-01

Lilly

bebtelovimab injection

175 mg/2 mL (87.5 mg/mL)

For Intravenous Use Only

Single-Dose Vial: Discard Unused Portion

For use under Emergency Use Authorization (EUA).

Betelovimab Injection 175 mg/2 mL (87.5 mg/mL) Vial Carton
(click image for full-size original)
BEBTELOVIMAB bebtelovimab injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0002-7589
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Bebtelovimab (Bebtelovimab) Bebtelovimab 87.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Histidine 0.4 mg in 1 mL
Histidine Monohydrochloride Monohydrate 0.6 mg in 1 mL
Sucrose 60 mg in 1 mL
Sodium Chloride 2.9 mg in 1 mL
Polysorbate 80 0.5 mg in 1 mL
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0002-7589-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 2 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0002-7589-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Emergency Use Authorization 02/11/2022
Labeler — Eli Lilly and Company (006421325)
Registrant — Eli Lilly and Company (006421325)

Revised: 08/2022 Eli Lilly and Company

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