Etesevimab

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 006421325

Effective Date

January 24, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Etesevimab(35 mg in 1 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

DUNS Number

006421325

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

0002-7950

Route of Administration

INTRAVENOUS

Effective Date

August 11, 2021

Ingredients

Code: N7Q9NLF11IClass: ACTIBQuantity: 35 mg in 1 mL

HistidineInactive

Code: 4QD397987EClass: IACTQuantity: 1.55 mg in 1 mL

WaterInactive

Code: 059QF0KO0RClass: IACT

Histidine Monohydrochloride MonohydrateInactive

Code: X573657P6PClass: IACTQuantity: 2.10 mg in 1 mL

SucroseInactive

Code: C151H8M554Class: IACTQuantity: 80.4 mg in 1 mL

Polysorbate 80Inactive

Code: 6OZP39ZG8HClass: IACTQuantity: 0.50 mg in 1 mL