FDA.reportPublic FDA data

1 ML hyaluronidase, human recombinant 150 UNT/ML Injection [Hylenex]

RxCUI
630939
RxNorm name
1 ML hyaluronidase, human recombinant 150 UNT/ML Injection [Hylenex]
Display name
1 ML hyaluronidase, human recombinant 150 UNT/ML Injection [Hylenex]
Full name
1 ML hyaluronidase, human recombinant 150 UNT/ML Injection [Hylenex]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:52

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021859Hylenex recombinanthyaluronidase human351(a)Rx2026-08-01

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYLENEX RecombinantHYALURONIDASEAntares Pharma, Inc.3023cc56-ed4b-4e87-b3a1-81b20943f6582024-11-11Warnings, Adverse reactionsExact identifier
rxcui: 630939
HYALURONIDASEHYALURONIDASEHF Acquisition Co LLC, DBA HealthFirstc3f1db01-58bf-2226-e053-2a95a90a8b332021-06-04Warnings, Adverse reactionsExact identifier
rxcui: 630939

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
3023cc56-ed4b-4e87-b3a1-81b20943f658Hylenex 150 UNT in 1 ML Injection [PSN] · 1 ML hyaluronidase, human recombinant 150 UNT/ML Injection [Hylenex] [SBD] · Hylenex 150 UNT per 1 ML Injection [SY]311These highlights do not include all the information needed to use HYLENEX recombinant safely and effectively. See full prescribing information for HYLENEX recombinant. HYLENEX recombinant (hyaluronidase) injection for infiltration use, for interstitial use, for intramuscular use, for intraocular use, for peribulbar use, retrobulbar use, for soft tissue use or for subcutaneous use Initial U.S. Approval: 200520241111
c3f1db01-58bf-2226-e053-2a95a90a8b33Hylenex 150 UNT in 1 ML Injection [PSN] · 1 ML hyaluronidase, human recombinant 150 UNT/ML Injection [Hylenex] [SBD] · Hylenex 150 UNT per 1 ML Injection [SY]31HYLENEX® RECOMBINANT 1mL (HYALURONIDASE HUMAN INJECTION) 150 USP UNITS/mL 1mL VIAL20210604