r or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125402 09/12/2014
Part 2 of 2
RECOMBINANT HUMAN HYALURONIDASE
hyaluronidase (human recombinant) solution
Product Information
Item Code (Source) NDC:0944-2724
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYALURONIDASE (HUMAN RECOMBINANT) (UNII: 743QUY4VD8) (HYALURONIDASE (HUMAN RECOMBINANT) - UNII:743QUY4VD8) HYALURONIDASE (HUMAN RECOMBINANT) 160 [USP'U] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE (UNII: SE337SVY37)
ALBUMIN HUMAN (UNII: ZIF514RVZR)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0944-2724-03 15 mL in 1 VIAL, GLASS; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125402 09/12/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125402 09/12/2014
Labeler - Baxalta US Inc. (079887619)
Establishment
Name Address ID/FEI Business Operations
Baxter SA 370191025 MANUFACTURE(0944-2510, 0944-2511, 0944-2512, 0944-2513, 0944-2514)
