FDA.reportPublic FDA data

Truxima

Product NDC
63459-103
11-digit product format
634590103
Labeler code
63459
Product ID
63459-103_de5d8106-44b8-4510-9129-f6a163c5231e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rituximab-abbs
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Cephalon, Inc.
Application
BLA761088
Marketing category
BLA
Marketing start
2020-05-04
Substance
RITUXIMAB
Active strength
10 mg/mL
Pharmacologic classes
CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RITUXIMAB10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4F4X42SYQ6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2105826Internal RxNorm lookup
2105831Internal RxNorm lookup
2105834Internal RxNorm lookup
2105835Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9af3ddc7-4217-417a-ac89-8704edc5bc44Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
37187acd-f290-495b-addd-d6d252de503bProduct name120210609
53df6cbe-2f85-495d-8a25-0d580b91ff46Product name120180806
4597a7a9-59c8-4eb4-b516-4f26fa3dfe4bProduct name120170804

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63459-103-10Truxima10 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION1015
63459-103-10Truxima1 in 1 CARTONINJECTION, SOLUTION115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63459-103-10ML - Milliliter63459-103fb1196f5-2206-42a6-bd64-1a4ad211a9eb12019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63459-103TRUXIMA (RITUXIMAB-ABBS) INJECTION, SOLUTION [CEPHALON, INC.]14Current NDC, Legacy NDC, 2 package rows20241222_9af3ddc7-4217-417a-ac89-8704edc5bc44.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
TruximaRITUXIMAB-ABBSCephalon, Inc.9af3ddc7-4217-417a-ac89-8704edc5bc442026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761088
ndc (product): 63459-103

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761088Truximarituximab-abbs351(k) InterchangeableRx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2105826riTUXimab-abbs 100 MG in 10 ML InjectionPSN9af3ddc7-4217-417a-ac89-8704edc5bc4415
2105834riTUXimab-abbs 500 MG in 50 ML InjectionPSN9af3ddc7-4217-417a-ac89-8704edc5bc4415
2105831Truxima 100 MG in 10 ML InjectionPSN9af3ddc7-4217-417a-ac89-8704edc5bc4415
2105835Truxima 500 MG in 50 ML InjectionPSN9af3ddc7-4217-417a-ac89-8704edc5bc4415
210583110 ML rituximab-abbs 10 MG/ML Injection [Truxima]SBD9af3ddc7-4217-417a-ac89-8704edc5bc4415
210583550 ML rituximab-abbs 10 MG/ML Injection [Truxima]SBD9af3ddc7-4217-417a-ac89-8704edc5bc4415
210582610 ML rituximab-abbs 10 MG/ML InjectionSCD9af3ddc7-4217-417a-ac89-8704edc5bc4415
210583450 ML rituximab-abbs 10 MG/ML InjectionSCD9af3ddc7-4217-417a-ac89-8704edc5bc4415
210583110 ML Truxima 10 MG/ML InjectionSY9af3ddc7-4217-417a-ac89-8704edc5bc4415
210583550 ML Truxima 10 MG/ML InjectionSY9af3ddc7-4217-417a-ac89-8704edc5bc4415
2105826rituximab-abbs 100 MG per 10 ML InjectionSY9af3ddc7-4217-417a-ac89-8704edc5bc4415
2105834rituximab-abbs 500 MG per 50 ML InjectionSY9af3ddc7-4217-417a-ac89-8704edc5bc4415
2105831Truxima 100 MG per 10 ML InjectionSY9af3ddc7-4217-417a-ac89-8704edc5bc4415
2105835Truxima 500 MG per 50 ML InjectionSY9af3ddc7-4217-417a-ac89-8704edc5bc4415

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63459-103-10634590103101 VIAL, SINGLE-USE in 1 CARTON (63459-103-10) / 10 mL in 1 VIAL, SINGLE-USE2020-05-040000-00-00NoNoCurrent