Pentoxifyllline Powder
NDC Package 17337-0426-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Pentoxifyllline powders is a medication used to improve the symptoms of a certain blood flow problem in the legs/arms (intermittent claudication due to occlusive artery disease). This formulation utilizes a powder delivery system. Marketed by Olon S.p.a., this product is identified by NDC 17337-0426.

Identification & Billing

NDC Package Code
17337-0426-0
Package Description
1 BAG in 1 DRUM / 1 BAG in 1 BAG / 25 kg in 1 BAG
Product Code
17337-0426
11-Digit Billing Format
17337042600

Clinical Specifications

Proprietary Name
Pentoxifyllline
Non-Proprietary Name
Pentoxifyllline
Substance Name
Pentoxifylline
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
PENTOXIFYLLINE 1 kg/kg
Usage Information
This medication is used to improve the symptoms of a certain blood flow problem in the legs/arms (intermittent claudication due to occlusive artery disease). Pentoxifylline can decrease the muscle aching/pain/cramps during exercise, including walking, that occur with intermittent claudication. Pentoxifylline belongs to a class of drugs known as hemorrheologic agents. It works by helping blood flow more easily through narrowed arteries. This increases the amount of oxygen that can be delivered by the blood when the muscles need more (such as during exercise) thereby increasing walking distance and duration.

Regulatory & Marketing

Labeler Name
Olon S.p.a.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
12-12-2017
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

Hierarchy Structure

Code Lineage

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.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 17337-0426-0 identifies a specific commercial package of 1 bag in 1 drum / 1 bag in 1 bag / 25 kg in 1 bag of Pentoxifyllline (UNFINISHED drug), a bulk ingredient labeled by Olon S.p.a.. This powder is formulated for use and contains pentoxifylline as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Olon S.p.a. on December 12, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to improve the symptoms of a certain blood flow problem in the legs/arms (intermittent claudication due to occlusive artery disease). Pentoxifylline can decrease the muscle aching/pain/cramps during exercise, including walking, that occur with intermittent claudication. Pentoxifylline belongs to a class of drugs known as hemorrheologic agents. It works by helping blood flow more easily through narrowed arteries. This increases the amount of oxygen that can be delivered by the blood when the muscles need more (such as during exercise) thereby increasing walking distance and duration.

How is this Olon S.p.a. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17337042600. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
17337-0426-0
11-Digit CMS (5-4-2)
17337-0426-00

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.