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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOSUNETUZUMAB1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLDJ89SS0YG
Rxcui2625129, 2625135, 2625137, 2625138

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

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