NDC 67457-594

Arixtra

Fondaparinux Sodium

Arixtra is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Fondaparinux Sodium.

Product ID67457-594_348fba8c-8c70-48da-b0d6-15c3f2b995c3
NDC67457-594
Product TypeHuman Prescription Drug
Proprietary NameArixtra
Generic NameFondaparinux Sodium
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2016-02-11
Marketing CategoryNDA / NDA
Application NumberNDA021345
Labeler NameMylan Institutional LLC
Substance NameFONDAPARINUX SODIUM
Active Ingredient Strength8 mg/.6mL
Pharm ClassesFactor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 67457-594-06

10 SYRINGE, PLASTIC in 1 CARTON (67457-594-06) > .6 mL in 1 SYRINGE, PLASTIC (67457-594-00)
Marketing Start Date2016-02-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-594-06 [67457059406]

Arixtra INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021345
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-02-11

NDC 67457-594-00 [67457059400]

Arixtra INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021345
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-02-11

NDC 67457-594-02 [67457059402]

Arixtra INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021345
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-02-11
Marketing End Date2015-08-18

Drug Details

Active Ingredients

IngredientStrength
FONDAPARINUX SODIUM7.5 mg/.6mL

OpenFDA Data

SPL SET ID:d3b30c68-cf45-4b46-8ba6-72090f7ba01a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861366
  • 861364
  • 861365
  • 861362
  • 861363
  • 861360
  • 861358
  • 861356
  • Pharmacological Class

    • Factor Xa Inhibitor [EPC]
    • Factor Xa Inhibitors [MoA]

    NDC Crossover Matching brand name "Arixtra" or generic name "Fondaparinux Sodium"

    NDCBrand NameGeneric Name
    67457-592ArixtraArixtra
    67457-593ArixtraArixtra
    67457-594ArixtraArixtra
    67457-595ArixtraArixtra
    0781-3443Fondaparinux SodiumFondaparinux Sodium
    0781-3454Fondaparinux SodiumFondaparinux Sodium
    0781-3465Fondaparinux SodiumFondaparinux Sodium
    0781-3476Fondaparinux SodiumFondaparinux Sodium
    11797-154fondaparinux sodiumfondaparinux sodium
    11797-155fondaparinux sodiumfondaparinux sodium
    11797-156fondaparinux sodiumfondaparinux sodium
    11797-157fondaparinux sodiumfondaparinux sodium
    43598-606Fondaparinux SodiumFondaparinux Sodium
    43598-607Fondaparinux SodiumFondaparinux Sodium
    43598-608Fondaparinux SodiumFondaparinux Sodium
    43598-609Fondaparinux SodiumFondaparinux Sodium

    Trademark Results [Arixtra]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ARIXTRA
    ARIXTRA
    76251411 2823751 Live/Registered
    MYLAN INSTITUTIONAL INC.
    2001-05-04
    ARIXTRA
    ARIXTRA
    76251409 2725323 Live/Registered
    MYLAN INSTITUTIONAL INC.
    2001-05-04
    ARIXTRA
    ARIXTRA
    75651561 2321564 Live/Registered
    MYLAN INSTITUTIONAL INC.
    1999-03-02

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