FDA.reportPublic FDA data

BRIUMVI

Product NDC
73150-150
11-digit product format
731500150
Labeler code
73150
Product ID
73150-150_4b34fc66-ea84-161b-e063-6294a90ac575
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ublituximab
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
TG Therapeutics, Inc.
Application
BLA761238
Marketing category
BLA
Marketing start
2022-12-28
Substance
UBLITUXIMAB
Active strength
150 mg/6mL
Pharmacologic classes
CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UBLITUXIMAB150 mg/6mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U59UGK3IPCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2626353Internal RxNorm lookup
2626359Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3a77cd8c-811b-407c-9140-d0c5c26435c2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1cdca8d5-f4ba-4a44-97ba-7dce2988c07dProduct name120231025

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73150-150-06BRIUMVI6 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE621
73150-150-06BRIUMVI1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73150-150-06ML - Milliliter73150-15028149fbd-05c1-4b7e-9776-040b8534bf5512023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73150-150BRIUMVI (UBLITUXIMAB) INJECTION, SOLUTION, CONCENTRATE [TG THERAPEUTICS, INC.]16Current NDC, Legacy NDC, 2 package rows20250213_3a77cd8c-811b-407c-9140-d0c5c26435c2.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BRIUMVIUBLITUXIMABTG Therapeutics, Inc.3a77cd8c-811b-407c-9140-d0c5c26435c22026-02-19Warnings, Adverse reactionsExact identifier
application number: BLA761238
ndc (product): 73150-150

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761238Briumviublituximab-xiiy351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2626359Briumvi 150 MG in 6 ML InjectionPSN3a77cd8c-811b-407c-9140-d0c5c26435c221
2626353ublituximab-xiiy 150 MG in 6 ML InjectionPSN3a77cd8c-811b-407c-9140-d0c5c26435c221
26263596 ML ublituximab-xiiy 25 MG/ML Injection [Briumvi]SBD3a77cd8c-811b-407c-9140-d0c5c26435c221
26263536 ML ublituximab-xiiy 25 MG/ML InjectionSCD3a77cd8c-811b-407c-9140-d0c5c26435c221
26263596 ML Briumvi 25 MG/ML InjectionSY3a77cd8c-811b-407c-9140-d0c5c26435c221
2626359Briumvi 150 MG per 6 ML InjectionSY3a77cd8c-811b-407c-9140-d0c5c26435c221
2626353ublituximab-xiiy 150 MG per 6 ML InjectionSY3a77cd8c-811b-407c-9140-d0c5c26435c221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
73150-150-06731500150061 VIAL, SINGLE-DOSE in 1 CARTON (73150-150-06) / 6 mL in 1 VIAL, SINGLE-DOSE2022-12-280000-00-00NoNoCurrent