HYALURONIDASE

Product NDC
51662-1555
11-digit product format
516621555
Labeler code
51662
Product ID
51662-1555_c3f1db01-58c0-2226-e053-2a95a90a8b33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYALURONIDASE
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
BLA021859
Marketing category
BLA
Marketing start
2021-06-04
Substance
HYALURONIDASE (HUMAN RECOMBINANT)
Active strength
150 [USP'U]/mL
Pharmacologic classes
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
HYALURONIDASE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYALURONIDASE (HUMAN RECOMBINANT)150 [USP'U]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
630936Internal RxNorm lookup
630939Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c3f1db01-58bf-2226-e053-2a95a90a8b33Available 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
bd11614e-4776-4a92-aaca-2bcbb5f710edProduct name120210115
0c6eff6a-9a1e-468b-b9ca-6bc864c2e8cbProduct name120200925
6d78c268-2e9d-bd45-9f2d-965fd0e582caProduct name220200323
980b5d64-e8e5-e1c9-b721-75e08f4e00a1Product name220200323
b914e981-d6dc-4748-bd51-accd6b85b817Product name120190618
4597a7a9-59c8-4eb4-b516-4f26fa3dfe4bProduct name120170804
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1555-1HYALURONIDASE1 mL in 1 VIALINJECTION, SOLUTION11
51662-1555-1HYALURONIDASE1 in 1 BOXINJECTION, SOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1555HYALURONIDASE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]1Current NDC, Legacy NDC, 2 package rows20210606_c3f1db01-58bf-2226-e053-2a95a90a8b33.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 · 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
application number: BLA021859
HYALURONIDASEHYALURONIDASEHF Acquisition Co LLC, DBA HealthFirstc3f1db01-58bf-2226-e053-2a95a90a8b332021-06-04Warnings, Adverse reactionsExact identifier
application number: BLA021859
ndc (product): 51662-1555

Purple Book Biologic Products#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630936hyaluronidase, human recombinant 150 UNT in 1 ML InjectionPSNc3f1db01-58bf-2226-e053-2a95a90a8b331
630939Hylenex 150 UNT in 1 ML InjectionPSNc3f1db01-58bf-2226-e053-2a95a90a8b331
6309391 ML hyaluronidase, human recombinant 150 UNT/ML Injection [Hylenex]SBDc3f1db01-58bf-2226-e053-2a95a90a8b331
6309361 ML hyaluronidase, human recombinant 150 UNT/ML InjectionSCDc3f1db01-58bf-2226-e053-2a95a90a8b331
630936hyaluronidase, human recombinant 150 UNT per 1 ML InjectionSYc3f1db01-58bf-2226-e053-2a95a90a8b331
630939Hylenex 150 UNT per 1 ML InjectionSYc3f1db01-58bf-2226-e053-2a95a90a8b331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1555-1516621555011 VIAL in 1 BOX (51662-1555-1) / 1 mL in 1 VIAL1 vial2021-06-040000-00-00NoNoCurrent