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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 human injection) for infiltration use, for interstitial use, for intramuscular use, for intraocular use, for peribulbar use, retrobulbar use, for soft tissue use and for subcutaneous use Initial U.S. Approval: 2005

Approved
Approval ID

75f75f29-e369-449d-aa46-179ae02d1fe9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 4, 2023

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

Products 1

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

Hyaluronidase (Human Recombinant)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50090-4534
Application NumberBLA021859
Product Classification
M
Marketing Category
C73585
G
Generic Name
Hyaluronidase (Human Recombinant)
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 1, 2016
FDA Product Classification

INGREDIENTS (8)

HYALURONIDASE (HUMAN RECOMBINANT)Active
Quantity: 150 [USP'U] in 1 mL
Code: 743QUY4VD8
Classification: ACTIB
sodium chlorideInactive
Quantity: 8.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Quantity: 1.4 mg in 1 mL
Code: GR686LBA74
Classification: IACT
albumin humanInactive
Quantity: 1 mg in 1 mL
Code: ZIF514RVZR
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
MethionineInactive
Quantity: 1.5 mg in 1 mL
Code: AE28F7PNPL
Classification: IACT
polysorbate 80Inactive
Quantity: 0.2 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT

Drug Labeling Information

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 2/4/2023

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-4534

NDC: 50090-4534-0 1 mL in a VIAL

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HYLENEX Recombinant - FDA Drug Approval Details