Sotrovimab

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

Company

DUNS: 167380711

Effective Date

March 16, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Sotrovimab(62.5 mg in 1 mL)

Products1

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

NDC Product Code

0173-0901

Route of Administration

INTRAVENOUS

Effective Date

May 26, 2021

Ingredients

Code: 1MTK0BPN8VClass: ACTIBQuantity: 62.5 mg in 1 mL

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

HISTIDINE MONOHYDROCHLORIDEInactive

Code: 1D5Q932XM6Class: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

METHIONINEInactive

Code: AE28F7PNPLClass: IACT