Sotrovimab
FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION FOR SOTROVIMAB
Approved
Approval ID
aa5cca2e-4351-4f81-b0e5-3303ac0b2474
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 16, 2023
Manufacturers
FDA
GlaxoSmithKline LLC
DUNS: 167380711
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sotrovimab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0901
Product Classification
G
Generic Name
sotrovimab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 26, 2021
FDA Product Classification
INGREDIENTS (5)
SOTROVIMABActive
Quantity: 62.5 mg in 1 mL
Code: 1MTK0BPN8V
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HISTIDINE MONOHYDROCHLORIDEInactive
Code: 1D5Q932XM6
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
METHIONINEInactive
Code: AE28F7PNPL
Classification: IACT