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HYALURONIDASE

HYLENEX® RECOMBINANT 1mL (HYALURONIDASE HUMAN INJECTION) 150 USP UNITS/mL 1mL VIAL

Approved
Approval ID

c3f1db01-58bf-2226-e053-2a95a90a8b33

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 4, 2021

Manufacturers
FDA

HF Acquisition Co LLC, DBA HealthFirst

DUNS: 045657305

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

HYALURONIDASE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51662-1555
Application NumberBLA021859
Product Classification
M
Marketing Category
C73585
G
Generic Name
HYALURONIDASE
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJune 4, 2021
FDA Product Classification

INGREDIENTS (8)

SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Quantity: 1.4 mg in 1 mL
Code: GR686LBA74
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
ALBUMIN HUMANInactive
Quantity: 1 mg in 1 mL
Code: ZIF514RVZR
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.2 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
METHIONINEInactive
Quantity: 1.5 mg in 1 mL
Code: AE28F7PNPL
Classification: IACT
HYALURONIDASE (HUMAN RECOMBINANT)Active
Quantity: 150 [USP'U] in 1 mL
Code: 743QUY4VD8
Classification: ACTIB

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HYALURONIDASE - FDA Drug Approval Details