NDC 11797-157

fondaparinux sodium

Fondaparinux Sodium

fondaparinux sodium is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Italfarmaco S.p.a. The primary component is Fondaparinux Sodium.

Product ID11797-157_39ad9bc7-5c3d-4d74-8d6f-873971520356
NDC11797-157
Product TypeHuman Prescription Drug
Proprietary Namefondaparinux sodium
Generic NameFondaparinux Sodium
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2019-02-06
Marketing CategoryANDA / ANDA
Application NumberANDA208615
Labeler NameItalfarmaco S.p.A
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 11797-157-06

10 SYRINGE in 1 CARTON (11797-157-06) > .8 mL in 1 SYRINGE (11797-157-02)
Marketing Start Date2019-02-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11797-157-02 [11797015702]

fondaparinux sodium INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA208615
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-06

NDC 11797-157-09 [11797015709]

fondaparinux sodium INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA208615
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-06

NDC 11797-157-06 [11797015706]

fondaparinux sodium INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA208615
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-06

Drug Details

Active Ingredients

IngredientStrength
FONDAPARINUX SODIUM10 mg/.8mL

OpenFDA Data

SPL SET ID:58789e3d-e5bc-4c2e-a527-495a252fcecd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861356
  • 861365
  • 861363
  • 861360
  • UPC Code
  • 0311797157090
  • 0311797155065
  • 0311797157069
  • 0311797156093
  • 0311797154068
  • 0311797156062
  • 0311797154099
  • 0311797155096
  • 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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