HYLENEX Recombinant

Effective Date

February 4, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Manufacturing Establishments (1)

Labeler

A-S Medication Solutions

DUNS Number

830016429

NDC Product Code

50090-4534

Application Number

BLA021859

Marketing Category

BLA (C73585)

Route of Administration

SUBCUTANEOUS

Effective Date

February 1, 2016

Ingredients

Code: 743QUY4VD8Class: ACTIBQuantity: 150 [USP'U] in 1 mL

sodium chlorideInactive

Code: 451W47IQ8XClass: IACTQuantity: 8.5 mg in 1 mL

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive

Code: GR686LBA74Class: IACTQuantity: 1.4 mg in 1 mL

albumin humanInactive

Code: ZIF514RVZRClass: IACTQuantity: 1 mg in 1 mL

sodium hydroxideInactive

Code: 55X04QC32IClass: IACT

MethionineInactive

Code: AE28F7PNPLClass: IACTQuantity: 1.5 mg in 1 mL

polysorbate 80Inactive

Code: 6OZP39ZG8HClass: IACTQuantity: 0.2 mg in 1 mL

hydrochloric acidInactive

Code: QTT17582CBClass: IACT

Product: 50090-4534

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