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
IngredientStrength
RITUXIMAB10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4F4X42SYQ6
Rxcui1657862, 1657864, 1657867, 1657868

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
50242-053-06Rituxan1 in 1 CARTONINJECTION, SOLUTION136
50242-053-06Rituxan50 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION5036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-053-06ML - Milliliter50242-0533dbd56be-33e8-436d-9a24-66586882278712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
rituximabACTIVE INGREDIENT4F4X42SYQ6RITUXAN (RITUXIMAB) INJECTION, SOLUTION [GENENTECH, INC.]14
rituximabACTIVE MOIETY4F4X42SYQ6RITUXAN (RITUXIMAB) INJECTION, SOLUTION [GENENTECH, INC.]14
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HRITUXAN (RITUXIMAB) INJECTION, SOLUTION [GENENTECH, INC.]14
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XRITUXAN (RITUXIMAB) INJECTION, SOLUTION [GENENTECH, INC.]14
Trisodium Citrate DihydrateINACTIVE INGREDIENTB22547B95KRITUXAN (RITUXIMAB) INJECTION, SOLUTION [GENENTECH, INC.]14
WaterINACTIVE INGREDIENT059QF0KO0RRITUXAN (RITUXIMAB) INJECTION, SOLUTION [GENENTECH, INC.]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-053RITUXAN (RITUXIMAB) INJECTION, SOLUTION [GENENTECH, INC.]36Current NDC, Legacy NDC, 2 package rows20250108_b172773b-3905-4a1c-ad95-bab4b6126563.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1657864Rituxan 100 MG in 10 ML InjectionPSNb172773b-3905-4a1c-ad95-bab4b612656336
1657868Rituxan 500 MG in 50 ML InjectionPSNb172773b-3905-4a1c-ad95-bab4b612656336
1657862riTUXimab 100 MG in 10 ML InjectionPSNb172773b-3905-4a1c-ad95-bab4b612656336
1657867riTUXimab 500 MG in 50 ML InjectionPSNb172773b-3905-4a1c-ad95-bab4b612656336
165786410 ML rituximab 10 MG/ML Injection [Rituxan]SBDb172773b-3905-4a1c-ad95-bab4b612656336
165786850 ML rituximab 10 MG/ML Injection [Rituxan]SBDb172773b-3905-4a1c-ad95-bab4b612656336
165786210 ML rituximab 10 MG/ML InjectionSCDb172773b-3905-4a1c-ad95-bab4b612656336
165786750 ML rituximab 10 MG/ML InjectionSCDb172773b-3905-4a1c-ad95-bab4b612656336
1657864Rituxan 100 MG per 10 ML InjectionSYb172773b-3905-4a1c-ad95-bab4b612656336
1657868Rituxan 500 MG per 50 ML InjectionSYb172773b-3905-4a1c-ad95-bab4b612656336
1657862rituximab 100 MG per 10 ML InjectionSYb172773b-3905-4a1c-ad95-bab4b612656336
1657867rituximab 500 MG per 50 ML InjectionSYb172773b-3905-4a1c-ad95-bab4b612656336

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50242-053-06502420053061 VIAL, SINGLE-USE in 1 CARTON (50242-053-06) / 50 mL in 1 VIAL, SINGLE-USE1997-11-260000-00-00NoNoCurrent