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