NDC 18657-117

HYLENEX Recombinant

Hyaluronidase (human Recombinant)

HYLENEX Recombinant is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Halozyme, Inc.. The primary component is Hyaluronidase (human Recombinant).

Product ID18657-117_308df247-a446-4284-8a1a-04410cd25e52
NDC18657-117
Product TypeHuman Prescription Drug
Proprietary NameHYLENEX Recombinant
Generic NameHyaluronidase (human Recombinant)
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2005-12-02
Marketing CategoryNDA / NDA
Application NumberNDA021859
Labeler NameHalozyme, Inc.
Substance NameHYALURONIDASE (HUMAN RECOMBINANT)
Active Ingredient Strength150 [USP'U]/mL
Pharm ClassesEndoglycosidase [EPC],Glycoside Hydrolases [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 18657-117-04

4 BOX in 1 CARTON (18657-117-04) > 1 VIAL in 1 BOX (18657-117-02) > 1 mL in 1 VIAL (18657-117-01)
Marketing Start Date2005-12-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 18657-117-02 [18657011702]

HYLENEX Recombinant INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021859
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-12-02

NDC 18657-117-01 [18657011701]

HYLENEX Recombinant INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021859
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-12-02

NDC 18657-117-10 [18657011710]

HYLENEX Recombinant INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021859
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-12-02
Marketing End Date2016-02-09

NDC 18657-117-04 [18657011704]

HYLENEX Recombinant INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021859
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-12-02

Drug Details

Active Ingredients

IngredientStrength
HYALURONIDASE (HUMAN RECOMBINANT)150 [USP'U]/mL

OpenFDA Data

SPL SET ID:3023cc56-ed4b-4e87-b3a1-81b20943f658
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 630936
  • 630939
  • Pharmacological Class

    • Endoglycosidase [EPC]
    • Glycoside Hydrolases [CS]

    NDC Crossover Matching brand name "HYLENEX Recombinant" or generic name "Hyaluronidase (human Recombinant)"

    NDCBrand NameGeneric Name
    18657-117HYLENEX RecombinantHyaluronidase (Human Recombinant)
    50090-4534HYLENEX RecombinantHyaluronidase (Human Recombinant)

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