NDC 0338-9576-12 Bivalirudin In 0.9% Sodium Chloride

Bivalirudin In 0.9% Sodium Chloride Injection

NDC Package Code 0338-9576-12

Field Name	Field Value
NDC Code	0338-9576-12
Package Description	12 BAG in 1 CARTON > 100 mL in 1 BAG
Proprietary Name	Bivalirudin In 0.9% Sodium Chloride 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	Bivalirudin In 0.9% Sodium Chloride Injection 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.
11-Digit NDC Billing Format	00338957612 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	Baxter Healthcare Corporation
Dosage Form	Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s)	Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)	BIVALIRUDIN 500 mg/100mL
Pharmacological Class(es)	Anti-coagulant - [EPC] (Established Pharmacologic Class) Direct Thrombin Inhibitor - [EPC] (Established Pharmacologic Class) Thrombin Inhibitors - [MoA] (Mechanism of Action)
Sample Package	No Sample Package? This field Indicates whether this package is a sample packaging or not.
Marketing Category	NDA - A product marketed under an approved 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	NDA208374 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	12-21-2017 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	12-31-2019 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.

The NDC Code 0338-9576-12 is assigned to Bivalirudin In 0.9% Sodium Chloride, a human prescription drug labeled by Baxter Healthcare Corporation. The product's dosage form is injection and is administered via intravenous form.

Code Structure

0338 - Baxter Healthcare Corporation
- 0338-9576 - Bivalirudin In 0.9% Sodium Chloride
  - 0338-9576-12 - 12 BAG 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 0338-9576-12 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
00338957612	J0583	Bivalirudin	1 MG	100	12	500	6000

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