67457-593 NDC - ARIXTRA (FONDAPARINUX SODIUM)

Drug Information

  • Product NDC: 67457-593
  • Proprietary Name: Arixtra
  • Non Proprietary Name: fondaparinux sodium
  • Active Ingredient(s): 5 mg/.4mL FONDAPARINUX SODIUM
  • Administration Route(s): SUBCUTANEOUS
  • Dosage Form(s): INJECTION, SOLUTION
  • Pharmacy Class(es): Factor Xa Inhibitor [EPC]; Factor Xa Inhibitors [MoA]

Labeler Information

Field Name Field Value
Labeler Name: Mylan Institutional LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA021345
Marketing Category: NDA
Start Marketing Date:5/19/2014

Package Information

No. Package Code Package Description Billing Unit
167457-593-0410 SYRINGE, GLASS in 1 CARTON (67457-593-04) / .4 mL in 1 SYRINGE, GLASS (67457-593-00)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC67457-593Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGThis corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
PROPRIETARY NAMEArixtraThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEfondaparinux sodiumThis is the date that the labeler indicates was the start of its marketing of the drug product.
DOSAGE FORM NAMEINJECTION, SOLUTIONProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
ROUTE NAMESUBCUTANEOUSThis corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
START MARKETING DATE5/19/2014Name of Company corresponding to the labeler code segment of the Product NDC.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA021345This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEMylan Institutional LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEFONDAPARINUX SODIUMAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH5 
ACTIVE INGRED UNITmg/.4mL 
PHARM CLASSESFactor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA] 

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This page was last updated on: 1/16/2026

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