Bebtelovimab
FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION FOR BEBTELOVIMAB
Approved
Approval ID
fd8dc07c-3aae-4cc2-a547-3a19357411ca
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 4, 2022
Manufacturers
FDA
Eli Lilly and Company
DUNS: 006421325
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bebtelovimab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0002-7589
Product Classification
G
Generic Name
Bebtelovimab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 11, 2022
FDA Product Classification
INGREDIENTS (7)
Polysorbate 80Inactive
Quantity: 0.5 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
BebtelovimabActive
Quantity: 87.5 mg in 1 mL
Code: 8YL4SYR6CU
Classification: ACTIB
Sodium ChlorideInactive
Quantity: 2.9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HistidineInactive
Quantity: 0.4 mg in 1 mL
Code: 4QD397987E
Classification: IACT
Histidine Monohydrochloride MonohydrateInactive
Quantity: 0.6 mg in 1 mL
Code: X573657P6P
Classification: IACT
SucroseInactive
Quantity: 60 mg in 1 mL
Code: C151H8M554
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT