FDA.reportPublic FDA data

MONJUVI

Product NDC
50881-013
11-digit product format
508810013
Labeler code
50881
Product ID
50881-013_a70f85e0-c22b-419a-9be2-51f575932633
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tafasitamab-cxix
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Incyte Corporation
Application
BLA761163
Marketing category
BLA
Marketing start
2020-08-05
Substance
TAFASITAMAB
Active strength
200 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MONJUVI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAFASITAMAB200 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QQA9MLH692Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2387338Internal RxNorm lookup
2387343Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9e0a220b-517f-4c86-b581-ffbab493fb58Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
430afe4e-a994-4b97-a099-6786b6d2b2bdProduct name120210223

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50881-013-03MONJUVI5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,512
50881-013-03MONJUVI1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50881-013-03EA - Each50881-0139ed35435-2d98-41c1-b2c8-28a07047df8512025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50881-013MONJUVI (TAFASITAMAB-CXIX) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [INCYTE CORPORATION]6Current NDC, 2 package rows20250131_9e0a220b-517f-4c86-b581-ffbab493fb58.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
MONJUVITAFASITAMAB-CXIXIncyte Corporationec13ac6b-bfde-4e84-907a-83bd69584d952026-02-02Warnings, Adverse reactionsExact identifier
application number: BLA761163
MONJUVITAFASITAMAB-CXIXIncyte Corporation9e0a220b-517f-4c86-b581-ffbab493fb582025-06-23Warnings, Adverse reactionsExact identifier
application number: BLA761163
ndc (product): 50881-013

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761163Monjuvitafasitamab-cxix351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2387343MONJUVI 200 MG InjectionPSN9e0a220b-517f-4c86-b581-ffbab493fb5812
2387338tafasitamab-cxix 200 MG InjectionPSN9e0a220b-517f-4c86-b581-ffbab493fb5812
2387343tafasitamab-cxix 200 MG Injection [Monjuvi]SBD9e0a220b-517f-4c86-b581-ffbab493fb5812
2387338tafasitamab-cxix 200 MG InjectionSCD9e0a220b-517f-4c86-b581-ffbab493fb5812
2387343Monjuvi 200 MG InjectionSY9e0a220b-517f-4c86-b581-ffbab493fb5812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50881-013-03508810013031 VIAL in 1 CARTON (50881-013-03) / 5 mL in 1 VIAL1 vial2020-08-05NoNoCurrent