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
NDC Product Code50242-159
Application NumberBLA761263
Marketing CategoryC73585
Route of AdministrationINTRAVENOUS
Effective DateDecember 22, 2022
Generic NameMosunetuzumab
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
NDC Product Code50242-142
Application NumberBLA761263
Marketing CategoryC73585
Route of AdministrationINTRAVENOUS
Effective DateDecember 22, 2022
Generic NameMosunetuzumab
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