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

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 Identifiers#

Field, Values table
FieldValues
UniiU59UGK3IPC
Rxcui2626353, 2626359

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

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