Home NDC 50242-053 Rituxan
Product NDC 50242-053
11-digit product format 502420053
Labeler code 50242
Product ID 50242-053_3a716937-c2af-4bf9-976c-c34746b22ff0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rituximab
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Genentech, Inc.
Application BLA103705
Marketing category BLA
Marketing start 1997-11-26
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 Rituxan
Listing expiration 2026-12-31 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 1657862 Internal RxNorm lookup 1657864 Internal RxNorm lookup 1657867 Internal RxNorm lookup 1657868 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 50242-053-06 Rituxan 1 in 1 CARTON INJECTION, SOLUTION 1 36 50242-053-06 Rituxan 50 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 50 36
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded rituximab ACTIVE INGREDIENT 4F4X42SYQ6 RITUXAN (RITUXIMAB) INJECTION, SOLUTION [GENENTECH, INC.] 14 rituximab ACTIVE MOIETY 4F4X42SYQ6 RITUXAN (RITUXIMAB) INJECTION, SOLUTION [GENENTECH, INC.] 14 Polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H RITUXAN (RITUXIMAB) INJECTION, SOLUTION [GENENTECH, INC.] 14 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X RITUXAN (RITUXIMAB) INJECTION, SOLUTION [GENENTECH, INC.] 14 Trisodium Citrate Dihydrate INACTIVE INGREDIENT B22547B95K RITUXAN (RITUXIMAB) INJECTION, SOLUTION [GENENTECH, INC.] 14 Water INACTIVE INGREDIENT 059QF0KO0R RITUXAN (RITUXIMAB) INJECTION, SOLUTION [GENENTECH, INC.] 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50242-053 RITUXAN (RITUXIMAB) INJECTION, SOLUTION [GENENTECH, INC.] 36 Current NDC, Legacy NDC, 2 package rows 20250108_b172773b-3905-4a1c-ad95-bab4b6126563.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.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103705 Rituxan rituximab 351(a) Rx 2026-07-01
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 50242-053-06 50242005306 1 VIAL, SINGLE-USE in 1 CARTON (50242-053-06) / 50 mL in 1 VIAL, SINGLE-USE 1997-11-26 0000-00-00 No No Current