FDA.reportPublic FDA data

Lunsumio Velo

Product NDC
50242-201
Requested package NDC
50242-201-01
11-digit product format
502420201
Labeler code
50242
Product ID
50242-201_9f54a0a1-d24b-429e-9a1b-393ed834f1a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mosunetuzumab
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Genentech, Inc.
Application
BLA761263
Marketing category
BLA
Marketing start
2025-12-19
Substance
MOSUNETUZUMAB
Active strength
45 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 Velo
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOSUNETUZUMAB45 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
2729433Internal RxNorm lookup
2729436Internal RxNorm lookup
2729439Internal RxNorm lookup
2729442Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6a2b6dc2-48bd-4da7-a611-bc6bae2893c8Available 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
50242-201-01Lunsumio Velo1 mL in 1 VIAL, GLASSINJECTION13
50242-201-01Lunsumio Velo1 in 1 CARTONINJECTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-201-01ML - Milliliter50242-2010b04d01a-279b-4d24-8907-650a1694654512026-02-05

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
Lunsumio VeloMOSUNETUZUMABGenentech, Inc.6a2b6dc2-48bd-4da7-a611-bc6bae2893c82026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761263
ndc (package): 50242-201-01
ndc (product): 50242-201
ndc11 (package): 50242020101

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761263Lunsumiomosunetuzumab-axgb351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2729436Lunsumio Velo 45 MG in 1 ML InjectionPSN6a2b6dc2-48bd-4da7-a611-bc6bae2893c83
2729442Lunsumio Velo 5 MG in 0.5 ML InjectionPSN6a2b6dc2-48bd-4da7-a611-bc6bae2893c83
2729433mosunetuzumab-axgb 45 MG in 1 ML InjectionPSN6a2b6dc2-48bd-4da7-a611-bc6bae2893c83
2729439mosunetuzumab-axgb 5 MG in 0.5 ML InjectionPSN6a2b6dc2-48bd-4da7-a611-bc6bae2893c83
27294420.5 ML mosunetuzumab-axgb 10 MG/ML Injection [Lunsumio]SBD6a2b6dc2-48bd-4da7-a611-bc6bae2893c83
27294361 ML mosunetuzumab-axgb 45 MG/ML Injection [Lunsumio]SBD6a2b6dc2-48bd-4da7-a611-bc6bae2893c83
27294390.5 ML mosunetuzumab-axgb 10 MG/ML InjectionSCD6a2b6dc2-48bd-4da7-a611-bc6bae2893c83
27294331 ML mosunetuzumab-axgb 45 MG/ML InjectionSCD6a2b6dc2-48bd-4da7-a611-bc6bae2893c83
2729442Lunsumio 10 MG/ML per 0.5 ML InjectionSY6a2b6dc2-48bd-4da7-a611-bc6bae2893c83
2729436Lunsumio 45 MG per 1 ML InjectionSY6a2b6dc2-48bd-4da7-a611-bc6bae2893c83
2729436Lunsumio 45 MG/ML per 1 ML InjectionSY6a2b6dc2-48bd-4da7-a611-bc6bae2893c83
2729442Lunsumio 5 MG per 0.5 ML InjectionSY6a2b6dc2-48bd-4da7-a611-bc6bae2893c83
2729439mosunetuzumab-axgb 10 MG/ML per 0.5 ML InjectionSY6a2b6dc2-48bd-4da7-a611-bc6bae2893c83
2729433mosunetuzumab-axgb 45 MG per 1 ML InjectionSY6a2b6dc2-48bd-4da7-a611-bc6bae2893c83
2729433mosunetuzumab-axgb 45 MG/ML per 1 ML InjectionSY6a2b6dc2-48bd-4da7-a611-bc6bae2893c83
2729439mosunetuzumab-axgb 5 MG per 0.5 ML InjectionSY6a2b6dc2-48bd-4da7-a611-bc6bae2893c83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50242-201-01502420201011 VIAL, GLASS in 1 CARTON (50242-201-01) / 1 mL in 1 VIAL, GLASS2025-12-19NoNoCurrent