NDC 55111-678-02 Fondaparinux Sodium
Injection Subcutaneous

Package Information

The NDC Code 55111-678-02 is assigned to a package of 2 syringe in 1 carton > .5 ml in 1 syringe (55111-678-11) of Fondaparinux Sodium, a human prescription drug labeled by Dr. Reddy's Laboratories Limited. The product's dosage form is injection and is administered via subcutaneous form.

Field Name Field Value
NDC Code 55111-678-02
Package Description 2 SYRINGE in 1 CARTON > .5 mL in 1 SYRINGE (55111-678-11)
Product Code 55111-678
Proprietary Name 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.
Fondaparinux Sodium
Non-Proprietary Name 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.
Fondaparinux Sodium
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
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 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.
55111067802
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Estimated Billable Units per Package 1.0 ML
NADAC Wholesale Price per Unit National Average Drug Acquisition Cost (NADAC)
The National Average Drug Acquisition Cost (NADAC) wholesale price per unit for NDC 55111-678-02 is $76.39600 and is up-to-date as of 05-11-2016. This product is billed per "ML" milliliter and contains an estimated amount of 1.0 billable units per package. The estimated wholesale price for the this package based on the lastest NADAC pricing survey is $76.40
$76.39600
Estimated Wholesale Price per Package $76.40
NDC to RxNorm Crosswalk
  • RxCUI: 861356 - fondaparinux sodium 10 MG in 0.8 ML Prefilled Syringe
  • RxCUI: 861356 - 0.8 ML fondaparinux sodium 12.5 MG/ML Prefilled Syringe
  • RxCUI: 861356 - fondaparinux sodium 10 MG per 0.8 ML Prefilled Syringe
  • RxCUI: 861360 - fondaparinux sodium 2.5 MG in 0.5 ML Prefilled Syringe
  • RxCUI: 861360 - 0.5 ML fondaparinux sodium 5 MG/ML Prefilled Syringe
  • Product Type 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.
    Human Prescription Drug
    Labeler Name Dr. Reddy's Laboratories Limited
    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)
    Pharmacologic Class(es)
    Sample Package Sample Package?
    This field Indicates whether this package is a sample packaging or not.
    No
    Marketing Category 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.
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    FDA Application Number 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.
    ANDA091316
    Start Marketing Date What is the Start Marketing Date?
    This is the date that the labeler indicates was the start of its marketing of the drug product.
    07-14-2011
    Listing Expiration Date 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.
    12-31-2022
    Exclude Flag 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".
    N
    NDC Code Structure

    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 55111-678-02 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    55111067802J1652Fondaparinux sodium0.5 MG0.52510

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    Other Product Packages

    The following packages are also available for Fondaparinux Sodium with product NDC 55111-678.

    NDC Package CodePackage Description
    55111-678-1010 SYRINGE in 1 CARTON > .5 mL in 1 SYRINGE (55111-678-11)

    * Please review the disclaimer below.