Home NDC 63459-104 Truxima
Product NDC 63459-104
11-digit product format 634590104
Labeler code 63459
Product ID 63459-104_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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Truxima
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RITUXIMAB 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4F4X42SYQ6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2105826 Internal RxNorm lookup 2105831 Internal RxNorm lookup 2105834 Internal RxNorm lookup 2105835 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63459-104-50 Truxima 1 in 1 CARTON INJECTION, SOLUTION 1 15 63459-104-50 Truxima 50 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 50 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63459-104 TRUXIMA (RITUXIMAB-ABBS) INJECTION, SOLUTION [CEPHALON, INC.] 14 Current NDC, Legacy NDC, 2 package rows 20241222_9af3ddc7-4217-417a-ac89-8704edc5bc44.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761088 Truxima rituximab-abbs 351(k) Biosimilar Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63459-104-50 63459010450 1 VIAL, SINGLE-USE in 1 CARTON (63459-104-50) / 50 mL in 1 VIAL, SINGLE-USE 2020-05-04 0000-00-00 No No Current