HYLENEX Recombinant
These 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: 2005
Approved
Approval ID
3023cc56-ed4b-4e87-b3a1-81b20943f658
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2024
Manufacturers
FDA
Antares Pharma, Inc.
DUNS: 085369585
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 Code18657-117
Application NumberBLA021859
Product Classification
M
Marketing Category
C73585
G
Generic Name
Hyaluronidase
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 24, 2024
FDA Product Classification
INGREDIENTS (8)
Hyaluronidase (Human Recombinant)Active
Quantity: 150 [USP'U] in 1 mL
Code: 743QUY4VD8
Classification: ACTIB
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
MethionineInactive
Quantity: 1.5 mg in 1 mL
Code: AE28F7PNPL
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
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT