Inmazeb
These highlights do not include all the information needed to use INMAZEB safely and effectively. See full prescribing information for INMAZEB. INMAZEB (atoltivimab, maftivimab, and odesivimab-ebgn) injection, for intravenous use Initial U.S. Approval: 2020
Approved
Approval ID
0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2022
Manufacturers
FDA
Regeneron Pharmaceuticals, Inc.
DUNS: 194873139
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
atoltivimab, maftivimab, and odesivimab-ebgn
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61755-019
Application NumberBLA761169
Product Classification
M
Marketing Category
C73585
G
Generic Name
atoltivimab, maftivimab, and odesivimab-ebgn
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 19, 2022
FDA Product Classification
INGREDIENTS (8)
atoltivimabActive
Quantity: 483.3 mg in 14.5 mL
Code: FJZ07Q63VY
Classification: ACTIB
maftivimabActive
Quantity: 483.3 mg in 14.5 mL
Code: KOP95331M4
Classification: ACTIB
odesivimabActive
Quantity: 483.3 mg in 14.5 mL
Code: UY9LQ8P6HW
Classification: ACTIB
HISTIDINEInactive
Code: 4QD397987E
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6P
Classification: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SucroseInactive
Code: C151H8M554
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
atoltivimab, maftivimab, and odesivimab-ebgn
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61755-018
Application NumberBLA761169
Product Classification
M
Marketing Category
C73585
G
Generic Name
atoltivimab, maftivimab, and odesivimab-ebgn
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 19, 2022
FDA Product Classification
INGREDIENTS (8)
atoltivimabActive
Quantity: 241.7 mg in 14.5 mL
Code: FJZ07Q63VY
Classification: ACTIB
maftivimabActive
Quantity: 241.7 mg in 14.5 mL
Code: KOP95331M4
Classification: ACTIB
HISTIDINEInactive
Code: 4QD397987E
Classification: IACT
odesivimabActive
Quantity: 241.7 mg in 14.5 mL
Code: UY9LQ8P6HW
Classification: ACTIB
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6P
Classification: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SucroseInactive
Code: C151H8M554
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT