NDC 0781-3443

Fondaparinux Sodium

Fondaparinux Sodium

Fondaparinux Sodium is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc.. The primary component is Fondaparinux Sodium.

Product ID0781-3443_7882a340-8edb-312c-e053-2991aa0a855d
NDC0781-3443
Product TypeHuman Prescription Drug
Proprietary NameFondaparinux Sodium
Generic NameFondaparinux Sodium
Dosage FormInjection
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2019-06-18
Marketing CategoryANDA / ANDA
Application NumberANDA206812
Labeler NameSandoz Inc.
Substance NameFONDAPARINUX SODIUM
Active Ingredient Strength3 mg/.5mL
Pharm ClassesFactor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0781-3443-12

2 SYRINGE in 1 CARTON (0781-3443-12) > .5 mL in 1 SYRINGE (0781-3443-94)
Marketing Start Date2019-06-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-3443-94 [00781344394]

Fondaparinux Sodium INJECTION
Marketing CategoryANDA
Application NumberANDA206812
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-18

NDC 0781-3443-12 [00781344312]

Fondaparinux Sodium INJECTION
Marketing CategoryANDA
Application NumberANDA206812
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-18

NDC 0781-3443-95 [00781344395]

Fondaparinux Sodium INJECTION
Marketing CategoryANDA
Application NumberANDA206812
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-18

Drug Details

Active Ingredients

IngredientStrength
FONDAPARINUX SODIUM2.5 mg/.5mL

OpenFDA Data

SPL SET ID:baa50757-a927-4d56-a933-5d7798fe6ab0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861356
  • 861365
  • 861363
  • 861360
  • Pharmacological Class

    • 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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