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
HYALURONIDASE (HUMAN RECOMBINANT)2000 U/mL
RITUXIMAB120 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii743QUY4VD8, 4F4X42SYQ6
Rxcui1927885, 1927890, 1927893, 1927894

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 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

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