NDC 55150-230

FONDAPARINUX SODIUM

Fondaparinux Sodium

FONDAPARINUX SODIUM is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Auromedics Pharma Llc. The primary component is Fondaparinux Sodium.

Product ID55150-230_8ea61d0d-4403-4d9f-a946-85a459cc0aa0
NDC55150-230
Product TypeHuman Prescription Drug
Proprietary NameFONDAPARINUX SODIUM
Generic NameFondaparinux Sodium
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2017-12-26
Marketing CategoryANDA / ANDA
Application NumberANDA206918
Labeler NameAuroMedics Pharma LLC
Substance NameFONDAPARINUX SODIUM
Active Ingredient Strength3 mg/.5mL
Pharm ClassesFactor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55150-230-02

2 SYRINGE, GLASS in 1 CARTON (55150-230-02) > .5 mL in 1 SYRINGE, GLASS (55150-230-00)
Marketing Start Date2017-12-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55150-230-02 [55150023002]

FONDAPARINUX SODIUM INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA206918
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-26

NDC 55150-230-00 [55150023000]

FONDAPARINUX SODIUM INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA206918
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-12-26

NDC 55150-230-10 [55150023010]

FONDAPARINUX SODIUM INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA206918
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-12-26

Drug Details

Active Ingredients

IngredientStrength
FONDAPARINUX SODIUM2.5 mg/.5mL

OpenFDA Data

SPL SET ID:8ea61d0d-4403-4d9f-a946-85a459cc0aa0
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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