FDA.reportPublic FDA data

Lunsumio

Product NDC
50242-159
11-digit product format
502420159
Labeler code
50242
Product ID
50242-159_2800ba90-bfda-4932-9aae-9ef9166cd7e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mosunetuzumab
Dosage form
CONCENTRATE
Route
INTRAVENOUS
Labeler
Genentech, Inc.
Application
BLA761263
Marketing category
BLA
Marketing start
2022-12-22
Substance
MOSUNETUZUMAB
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lunsumio
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOSUNETUZUMAB1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LDJ89SS0YGInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2625129Internal RxNorm lookup
2625135Internal RxNorm lookup
2625137Internal RxNorm lookup
2625138Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2ef0cf38-101c-4681-98fe-c05dc9ead443Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-159-01Lunsumio1 mL in 1 VIALCONCENTRATE16
50242-159-01Lunsumio1 in 1 CARTONCONCENTRATE16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-159-01ML - Milliliter50242-1597f7b20db-9bc6-49bc-b4d0-f984f713a83c12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-159LUNSUMIO (MOSUNETUZUMAB) CONCENTRATE [GENENTECH, INC.]5Current NDC, Legacy NDC, 2 package rows20241207_2ef0cf38-101c-4681-98fe-c05dc9ead443.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LunsumioMOSUNETUZUMABGenentech, Inc.2ef0cf38-101c-4681-98fe-c05dc9ead4432026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761263
ndc (product): 50242-159
Lunsumio VeloMOSUNETUZUMABGenentech, Inc.6a2b6dc2-48bd-4da7-a611-bc6bae2893c82026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761263

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761263Lunsumiomosunetuzumab-axgb351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2625135Lunsumio 1 MG in 1 ML InjectionPSN2ef0cf38-101c-4681-98fe-c05dc9ead4436
2625138Lunsumio 30 MG in 30 ML InjectionPSN2ef0cf38-101c-4681-98fe-c05dc9ead4436
2625129mosunetuzumab-axgb 1 MG in 1 ML InjectionPSN2ef0cf38-101c-4681-98fe-c05dc9ead4436
2625137mosunetuzumab-axgb 30 MG in 30 ML InjectionPSN2ef0cf38-101c-4681-98fe-c05dc9ead4436
26251351 ML mosunetuzumab-axgb 1 MG/ML Injection [Lunsumio]SBD2ef0cf38-101c-4681-98fe-c05dc9ead4436
262513830 ML mosunetuzumab-axgb 1 MG/ML Injection [Lunsumio]SBD2ef0cf38-101c-4681-98fe-c05dc9ead4436
26251291 ML mosunetuzumab-axgb 1 MG/ML InjectionSCD2ef0cf38-101c-4681-98fe-c05dc9ead4436
262513730 ML mosunetuzumab-axgb 1 MG/ML InjectionSCD2ef0cf38-101c-4681-98fe-c05dc9ead4436
2625135Lunsumio 1 MG per 1 ML InjectionSY2ef0cf38-101c-4681-98fe-c05dc9ead4436
2625135Lunsumio 1 MG/ML per 1 ML InjectionSY2ef0cf38-101c-4681-98fe-c05dc9ead4436
2625138Lunsumio 1 MG/ML per 30 ML InjectionSY2ef0cf38-101c-4681-98fe-c05dc9ead4436
2625138Lunsumio 30 MG per 30 ML InjectionSY2ef0cf38-101c-4681-98fe-c05dc9ead4436
2625129mosunetuzumab-axgb 1 MG per 1 ML InjectionSY2ef0cf38-101c-4681-98fe-c05dc9ead4436
2625129mosunetuzumab-axgb 1 MG/ML per 1 ML InjectionSY2ef0cf38-101c-4681-98fe-c05dc9ead4436
2625137mosunetuzumab-axgb 1 MG/ML per 30 ML InjectionSY2ef0cf38-101c-4681-98fe-c05dc9ead4436
2625137mosunetuzumab-axgb 30 MG per 30 ML InjectionSY2ef0cf38-101c-4681-98fe-c05dc9ead4436

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50242-159-01502420159011 VIAL in 1 CARTON (50242-159-01) / 1 mL in 1 VIAL1 vial2022-12-220000-00-00NoNoCurrent