NDC 43598-606

Fondaparinux Sodium

Fondaparinux Sodium

Fondaparinux Sodium is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Dr. Reddy's Laboratories Inc.. The primary component is Fondaparinux Sodium.

Product ID43598-606_744da4b5-af8a-7df3-a643-d27c95617ddc
NDC43598-606
Product TypeHuman Prescription Drug
Proprietary NameFondaparinux Sodium
Generic NameFondaparinux Sodium
Dosage FormInjection
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2017-07-27
Marketing CategoryANDA / ANDA
Application NumberANDA091316
Labeler NameDr. Reddy's Laboratories Inc.
Substance NameFONDAPARINUX SODIUM
Active Ingredient Strength10 mg/.8mL
Pharm ClassesFactor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43598-606-02

2 SYRINGE in 1 CARTON (43598-606-02) > .8 mL in 1 SYRINGE (43598-606-11)
Marketing Start Date2017-07-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43598-606-11 [43598060611]

Fondaparinux Sodium INJECTION
Marketing CategoryANDA
Application NumberANDA091316
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-07-27

NDC 43598-606-10 [43598060610]

Fondaparinux Sodium INJECTION
Marketing CategoryANDA
Application NumberANDA091316
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-07-27

NDC 43598-606-02 [43598060602]

Fondaparinux Sodium INJECTION
Marketing CategoryANDA
Application NumberANDA091316
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-07-27

Drug Details

Active Ingredients

IngredientStrength
FONDAPARINUX SODIUM10 mg/.8mL

OpenFDA Data

SPL SET ID:8a27f341-f612-de72-8c1f-3fd977905de0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861356
  • 861365
  • 861363
  • 861360

    • Pharmacological Class

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