NDC 60809-801

Krystexxa

Pegloticase

Krystexxa is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Horizon Pharma Inc.. The primary component is Pegloticase.

Product ID60809-801_e46925f2-7335-435e-8fe0-f4455fd01c74
NDC60809-801
Product TypeHuman Prescription Drug
Proprietary NameKrystexxa
Generic NamePegloticase
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2010-09-14
Marketing CategoryBLA / BLA
Application NumberBLA125293
Labeler NameHorizon Pharma Inc.
Substance NamePEGLOTICASE
Active Ingredient Strength8 mg/mL
Pharm ClassesUrate Oxidase [CS],Uric Acid-specific Enzyme [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 60809-801-01

1 VIAL in 1 CARTON (60809-801-01) > 1 mL in 1 VIAL
Marketing Start Date2010-09-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60809-801-01 [60809080101]

Krystexxa INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125293
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-09-14
Marketing End Date2018-12-31

Drug Details

Active Ingredients

IngredientStrength
PEGLOTICASE8 mg/mL

OpenFDA Data

SPL SET ID:9c0d9fbb-998c-4a62-9354-7330d64b144e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1011653
  • 1011657
  • Pharmacological Class

    • Urate Oxidase [CS]
    • Uric Acid-specific Enzyme [EPC]

    NDC Crossover Matching brand name "Krystexxa" or generic name "Pegloticase"

    NDCBrand NameGeneric Name
    54396-801Krystexxapegloticase
    60809-801Krystexxapegloticase
    75987-080Krystexxapegloticase

    Trademark Results [Krystexxa]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    KRYSTEXXA
    KRYSTEXXA
    77552516 3920201 Live/Registered
    HORIZON PHARMA RHEUMATOLOGY LLC
    2008-08-21

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