NDC 0781-3454-12 Fondaparinux Sodium

Fondaparinux Sodium

  1. Labeler Index
  2. Sandoz Inc.
  3. 0781-3454
  4. NDC Code: 0781-3454-12 Fondaparinux Sodium

NDC Package Code 0781-3454-12

The NDC Code 0781-3454-12 is assigned to a package of 2 syringe in 1 carton > .4 ml in 1 syringe (0781-3454-94) of Fondaparinux Sodium, a human prescription drug labeled by Sandoz Inc.. The product's dosage form is injection and is administered via subcutaneous form.

Field Name Field Value
NDC Code 0781-3454-12
Package Description 2 SYRINGE in 1 CARTON > .4 mL in 1 SYRINGE (0781-3454-94)
Proprietary Name Fondaparinux Sodium What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Fondaparinux Sodium What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Drug Uses Fondaparinux is used to treat serious blood clots in the legs and/or lungs. It is usually used with another "blood thinner" medication (warfarin). If untreated, blood clots can travel to the lungs, heart, or brain, causing serious (possibly fatal) breathing problems, heart attack, or stroke. This drug may also be used to prevent blood clots after certain surgeries with an increased risk of blood clots (such as hip fracture, abdominal, knee/hip replacement). Fondaparinux is known as a "blood thinner" (anticoagulant). It is a drug similar to heparin that works by blocking certain natural substances in the blood that cause clotting.
11-Digit NDC Billing Format 00781345412 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Product Type Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Labeler Name Sandoz Inc.
Dosage Form Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s)
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
  • FONDAPARINUX SODIUM 5 mg/.4mL
Pharmacological Class(es)
  • Factor Xa Inhibitor - [EPC] (Established Pharmacologic Class)
  • Factor Xa Inhibitors - [MoA] (Mechanism of Action)
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product 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.
FDA Application Number ANDA206812 What is the FDA Application Number?
This 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 Date 06-18-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

NDC Code Structure

  • 0781 - Sandoz Inc.
    • 0781-3454 - Fondaparinux Sodium
      • 0781-3454-12 - 2 SYRINGE in 1 CARTON

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 0781-3454-12 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
00781345412J1652Fondaparinux sodium0.5 MG0.421020

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Other Product Packages

The following packages are also available for Fondaparinux Sodium with product NDC 0781-3454.

NDC Package CodePackage Description
0781-3454-9510 SYRINGE in 1 CARTON > .4 mL in 1 SYRINGE (0781-3454-94)

* Please review the disclaimer below.