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


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
# 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 provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

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