NDC 55111-681-10 Fondaparinux Sodium

Fondaparinux Sodium

NDC Package Code 55111-681-10

The NDC Code 55111-681-10 is assigned to a package of 10 syringe in 1 carton > .8 ml in 1 syringe (55111-681-11) 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	55111-681-10
Package Description	10 SYRINGE in 1 CARTON > .8 mL in 1 SYRINGE (55111-681-11)
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	55111068110 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.
Billing Unit	ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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	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)	FONDAPARINUX SODIUM 10 mg/.8mL
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	ANDA091316 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	07-14-2011 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	12-31-2022 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

55111 - Dr. Reddy's Laboratories Limited
- 55111-681 - Fondaparinux Sodium
  - 55111-681-10 - 10 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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National Average Drug Acquisition Cost (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average drug invoice price paid by retail community pharmacies to wholesalers. The Centers for Medicare and Medicaid Services (CMS) compile the NADAC data based on random monthly surveys on more than 60,000 pharmacies from all 50 states and the District of Columbia. NADAC pricing information is NOT the price paid by end-customers but instead the price paid by pharmacies to drug wholesalers and distributors.

Field Name	Field Value
Price per Unit	$100.88425
Effective Date	02-18-2015 Effective Date The effective date of the NADAC Per Unit cost.
Pricing Unit	ML Pricing Unit Indicates the pricing unit for the associated NDC (ML, GM or EA).
Pharmacy Type Indicator	C/I - Chain or Independent Pharmacy Pharmacy Type Indicator The source of pharmacy survey data used to calculate the NADAC. 'C/I' indicates data was collected from surveys of Chain/Independent pharmacies. Other pharmacy type indicators are not used at this time.
Explanation Code	Code 4: The NADAC was carried forward from the previous file. Code 5: The NADAC was calculated based on package size. Explanation Code The source of pharmacy survey data used to calculate the NADAC. 'C/I' indicates data was collected from surveys of Chain/Independent pharmacies. Other pharmacy type indicators are not used at this time.
Classification for Rate Setting	G - Generic Classification for Rate Setting Indicates whether the NDC was considered brand (B) or generic (G) for the NADAC rate calculation process. If the NDC was considered brand (B) and approved under an Abbreviated New Drug Application (ANDA), the indicator is shown as (B-ANDA).
As of Date	03-16-2016

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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 55111-681-10 HCPCS crosswalk information with package details and bill units information.

NDC Billing Code	HCPCS Code	HCPCS Code Desc.	Dosage	Package Size	Package Quantity	Billable Units	Billable Units / Pkg
55111068110	J1652	Fondaparinux sodium	0.5 MG	0.8	10	20	200

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Other Product Packages

The following packages are also available for Fondaparinux Sodium with product NDC 55111-681.

NDC Package Code	Package Description
55111-681-02	2 SYRINGE in 1 CARTON > .8 mL in 1 SYRINGE (55111-681-11)

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