NDC Code(s) : 18657-102-01, 18657-102-02, 18657-102-04, 18657-102-10
Packager : Halozyme, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

HYLENEX RecombinantHyaluronidase (Human Recombinant) INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:18657-102
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hyaluronidase (Human Recombinant)(UNII: 743QUY4VD8)
(Hyaluronidase (Human Recombinant) - UNII:743QUY4VD8) 		Hyaluronidase (Human Recombinant)150 [USP'U] in 1 mL
Inactive Ingredients
Ingredient Name Strength
sodium chloride(UNII: 451W47IQ8X)8.5 mg in 1 mL
sodium phosphate, dibasic(UNII: GR686LBA74)1.4 mg in 1 mL
albumin human(UNII: ZIF514RVZR)1 mg in 1 mL
edetate disodium(UNII: 7FLD91C86K)0.9 mg in 1 mL
calcium chloride(UNII: M4I0D6VV5M)0.3 mg in 1 mL
sodium hydroxide(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:18657-102-044 in 1 CARTON
1NDC:18657-102-021 in 1 BOX
1NDC:18657-102-011 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:18657-102-1010 in 1 CARTON
2NDC:18657-102-021 in 1 BOX
2NDC:18657-102-011 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021859 12/02/2005

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 10 × 1 mL Single Dose Vial Carton

NDC 18657-102-10

Hylenex®
recombinant
(hyaluronidase
human injection)

10 x 1 mL

150 USP units/mL
NOT FOR IV USE
REFRIGERATE

Rx only

Single Dose Vials
HALOZYME THERAPEUTICS

Principal Display Panel - 10 × 1 mL Single Dose Vial Carton