Lunsumio
These highlights do not include all the information needed to use LUNSUMIO safely and effectively. See full prescribing information for LUNSUMIO. LUNSUMIO™ (mosunetuzumab-axgb) injection, for intravenous use Initial U.S. Approval: 2022
Approved
Approval ID
2ef0cf38-101c-4681-98fe-c05dc9ead443
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2022
Manufacturers
FDA
Genentech, Inc.
DUNS: 080129000
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mosunetuzumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50242-159
Application NumberBLA761263
Product Classification
M
Marketing Category
C73585
G
Generic Name
Mosunetuzumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 22, 2022
FDA Product Classification
INGREDIENTS (7)
MOSUNETUZUMABActive
Quantity: 1 mg in 1 mL
Code: LDJ89SS0YG
Classification: ACTIB
HISTIDINEInactive
Quantity: 1.6 mg in 1 mL
Code: 4QD397987E
Classification: IACT
ACETIC ACIDInactive
Quantity: 0.4 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
METHIONINEInactive
Quantity: 1.5 mg in 1 mL
Code: AE28F7PNPL
Classification: IACT
SUCROSEInactive
Quantity: 82.1 mg in 1 mL
Code: C151H8M554
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 0.6 mg in 1 mL
Code: 7T1F30V5YH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Mosunetuzumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50242-142
Application NumberBLA761263
Product Classification
M
Marketing Category
C73585
G
Generic Name
Mosunetuzumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 22, 2022
FDA Product Classification
INGREDIENTS (7)
HISTIDINEInactive
Quantity: 46.6 mg in 30 mL
Code: 4QD397987E
Classification: IACT
MOSUNETUZUMABActive
Quantity: 30 mg in 30 mL
Code: LDJ89SS0YG
Classification: ACTIB
ACETIC ACIDInactive
Quantity: 12.8 mg in 30 mL
Code: Q40Q9N063P
Classification: IACT
METHIONINEInactive
Quantity: 44.8 mg in 30 mL
Code: AE28F7PNPL
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCROSEInactive
Quantity: 2462.4 mg in 30 mL
Code: C151H8M554
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 18 mg in 30 mL
Code: 7T1F30V5YH
Classification: IACT