NDC 67457-585

Fondaparinux Sodium

Fondaparinux Sodium

Fondaparinux Sodium 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 ID67457-585_09da1394-44bc-42dc-a911-4a664881efa9
NDC67457-585
Product TypeHuman Prescription Drug
Proprietary NameFondaparinux Sodium
Generic NameFondaparinux Sodium
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2015-01-05
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021345
Labeler NameMylan Institutional LLC
Substance NameFONDAPARINUX SODIUM
Active Ingredient Strength10 mg/.8mL
Pharm ClassesFactor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 67457-585-08

10 SYRINGE in 1 CARTON (67457-585-08) > .8 mL in 1 SYRINGE (67457-585-00)
Marketing Start Date2015-01-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-585-02 [67457058502]

Fondaparinux Sodium INJECTION, SOLUTION
Marketing CategoryNDA authorized generic
Application NumberNDA021345
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-05
Marketing End Date2015-01-07

NDC 67457-585-00 [67457058500]

Fondaparinux Sodium INJECTION, SOLUTION
Marketing CategoryNDA authorized generic
Application NumberNDA021345
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-01-05

NDC 67457-585-08 [67457058508]

Fondaparinux Sodium INJECTION, SOLUTION
Marketing CategoryNDA authorized generic
Application NumberNDA021345
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-01-05

Drug Details

Active Ingredients

IngredientStrength
FONDAPARINUX SODIUM10 mg/.8mL

OpenFDA Data

SPL SET ID:4b65f642-87f7-4da5-a9c9-02cd1f8d9d16
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861356
  • 861365
  • 861363
  • 861360
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    70710-1515fondaparinux sodiumfondaparinux sodium
    70710-1514fondaparinux sodiumfondaparinux sodium
    70710-1517fondaparinux sodiumfondaparinux sodium
    70710-1516fondaparinux sodiumfondaparinux sodium
    55111-681Fondaparinux SodiumFondaparinux Sodium
    55111-678Fondaparinux SodiumFondaparinux Sodium
    55150-231FONDAPARINUX SODIUMFONDAPARINUX SODIUM
    55150-232FONDAPARINUX SODIUMFONDAPARINUX SODIUM
    55150-230FONDAPARINUX SODIUMFONDAPARINUX SODIUM
    55111-679Fondaparinux SodiumFondaparinux Sodium
    55111-680Fondaparinux SodiumFondaparinux Sodium
    55150-233FONDAPARINUX SODIUMFONDAPARINUX SODIUM
    67457-582Fondaparinux SodiumFondaparinux Sodium
    67457-583Fondaparinux SodiumFondaparinux Sodium
    67457-584Fondaparinux SodiumFondaparinux Sodium
    67457-585Fondaparinux SodiumFondaparinux Sodium

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