FDA.reportPublic FDA data

13.4 ML hyaluronidase, human recombinant 2000 UNT/ML / rituximab 120 MG/ML Injection [Rituxan Hycela]

RxCUI
1927894
RxNorm name
13.4 ML hyaluronidase, human recombinant 2000 UNT/ML / rituximab 120 MG/ML Injection [Rituxan Hycela]
Display name
13.4 ML hyaluronidase, human recombinant 2000 UNT/ML / rituximab 120 MG/ML Injection [Rituxan Hycela]
Full name
13.4 ML hyaluronidase, human recombinant 2000 UNT/ML / rituximab 120 MG/ML Injection [Rituxan Hycela]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:55

Purple Book Biologic Products#

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

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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
rxcui: 1927894

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
3e5b7e82-f018-4eaf-ae78-d6145a906b20Rituxan Hycela 1600 MG / 26,800 UNT in 13.4 ML Injection [PSN] · 13.4 ML hyaluronidase, human recombinant 2000 UNT/ML / rituximab 120 MG/ML Injection [Rituxan Hycela] [SBD] · Rituxan Hycela 1600 MG / 26,800 UNT per 13.4 ML Injection [SY]321These 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: 201720251215