FDA.reportPublic FDA data

Rituxan Hycela

Product NDC
50242-108
11-digit product format
502420108
Labeler code
50242
Product ID
50242-108_e8a259ac-2a09-4026-823c-f23cbcba6a2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rituximab and hyaluronidase
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Genentech, Inc.
Application
BLA761064
Marketing category
BLA
Marketing start
2017-06-22
Substance
HYALURONIDASE (HUMAN RECOMBINANT); RITUXIMAB
Active strength
2000; 120 U/mL; mg/mL
Pharmacologic classes
CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC], Endoglycosidase [EPC], Glycoside Hydrolases [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rituxan Hycela
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RITUXIMAB2000 U/mL
HYALURONIDASE (HUMAN RECOMBINANT)120 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
743QUY4VD8Internal UNII lookup
4F4X42SYQ6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1927885Internal RxNorm lookup
1927890Internal RxNorm lookup
1927893Internal RxNorm lookup
1927894Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3e5b7e82-f018-4eaf-ae78-d6145a906b20Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fba5a780-b52d-4964-b662-1526b044aec4Product name120260127
64196b0b-840e-435b-8afa-0b0e9d9cea99Product name120251024
4b151d8d-9b47-43df-bccb-6abc1c4e7194Product name120250331
d745a796-f789-46a3-afa3-79dead22a863Product name120250331
00bb4496-246c-4f2c-910a-2b2783035958Product name120231025
37187acd-f290-495b-addd-d6d252de503bProduct name120210609
bd11614e-4776-4a92-aaca-2bcbb5f710edProduct name120210115
0c6eff6a-9a1e-468b-b9ca-6bc864c2e8cbProduct name120200925
6d78c268-2e9d-bd45-9f2d-965fd0e582caProduct name220200323
b914e981-d6dc-4748-bd51-accd6b85b817Product name120190618
53df6cbe-2f85-495d-8a25-0d580b91ff46Product name120180806
4597a7a9-59c8-4eb4-b516-4f26fa3dfe4bProduct name120170804
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50242-108-012024-01-30C16284748780-11030e365-289b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use RITUXAN HYCELA safely and effectively. See full prescribing information for RITUXAN HYCELA. RITUXAN HYCELA ® (rituximab and hyaluronidase human) injection, for subcutaneous use Initial U.S. Approval: 2017
50242-108-862024-01-30C16284748780-11030e365-289b-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use RITUXAN HYCELA safely and effectively. See full prescribing information for RITUXAN HYCELA. RITUXAN HYCELA ® (rituximab and hyaluronidase human) injection, for subcutaneous use Initial U.S. Approval: 2017

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-108-01Rituxan Hycela11.7 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION11.721
50242-108-01Rituxan Hycela1 in 1 CARTONINJECTION, SOLUTION121
50242-108-86Rituxan Hycela11.7 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION11.721
50242-108-86Rituxan Hycela1 in 1 CARTONINJECTION, SOLUTION121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-108-01ML - Milliliter50242-108c37513e3-5f9f-4572-8f85-3d3fc2b08e4412017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-108RITUXAN HYCELA (RITUXIMAB AND HYALURONIDASE) INJECTION, SOLUTION [GENENTECH, INC.]18Current NDC, Legacy NDC, 4 package rows20241206_3e5b7e82-f018-4eaf-ae78-d6145a906b20.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
Rituxan HycelaRITUXIMAB AND HYALURONIDASEGenentech, Inc.3e5b7e82-f018-4eaf-ae78-d6145a906b202025-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761064
ndc (product): 50242-108

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761064Rituxan Hycelarituximab and hyaluronidase human351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1927890Rituxan Hycela 1400 MG / 23,400 UNT in 11.7 ML InjectionPSN3e5b7e82-f018-4eaf-ae78-d6145a906b2021
1927894Rituxan Hycela 1600 MG / 26,800 UNT in 13.4 ML InjectionPSN3e5b7e82-f018-4eaf-ae78-d6145a906b2021
1927885riTUXimab 1400 MG / hyaluronidase, human recombinant 23,400 UNT in 11.7 ML InjectionPSN3e5b7e82-f018-4eaf-ae78-d6145a906b2021
1927893riTUXimab 1600 MG / hyaluronidase, human recombinant 26,800 UNT in 13.4 mL InjectionPSN3e5b7e82-f018-4eaf-ae78-d6145a906b2021
192789011.7 ML hyaluronidase, human recombinant 2000 UNT/ML / rituximab 120 MG/ML Injection [Rituxan Hycela]SBD3e5b7e82-f018-4eaf-ae78-d6145a906b2021
192789413.4 ML hyaluronidase, human recombinant 2000 UNT/ML / rituximab 120 MG/ML Injection [Rituxan Hycela]SBD3e5b7e82-f018-4eaf-ae78-d6145a906b2021
192788511.7 ML hyaluronidase, human recombinant 2000 UNT/ML / rituximab 120 MG/ML InjectionSCD3e5b7e82-f018-4eaf-ae78-d6145a906b2021
192789313.4 ML hyaluronidase, human recombinant 2000 UNT/ML / rituximab 120 MG/ML InjectionSCD3e5b7e82-f018-4eaf-ae78-d6145a906b2021
1927890Rituxan Hycela 1400 MG / 23,400 UNT per 11.7 ML InjectionSY3e5b7e82-f018-4eaf-ae78-d6145a906b2021
1927894Rituxan Hycela 1600 MG / 26,800 UNT per 13.4 ML InjectionSY3e5b7e82-f018-4eaf-ae78-d6145a906b2021
1927885rituximab 1400 MG / hyaluronidase, human recombinant 23,400 UNT per 11.7 ML InjectionSY3e5b7e82-f018-4eaf-ae78-d6145a906b2021
1927893rituximab 1600 MG / hyaluronidase, human recombinant 26,800 UNT per 13.4 ML InjectionSY3e5b7e82-f018-4eaf-ae78-d6145a906b2021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50242-108-01502420108011 VIAL, SINGLE-DOSE in 1 CARTON (50242-108-01) / 11.7 mL in 1 VIAL, SINGLE-DOSE2017-06-220000-00-00NoNoCurrent
50242-108-86502420108861 VIAL, SINGLE-DOSE in 1 CARTON (50242-108-86) / 11.7 mL in 1 VIAL, SINGLE-DOSE2017-06-230000-00-00YesNoCurrent