Pentoxifylline Powder
NDC Package 72643-032-03

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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.

Pentoxifylline 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 Solara Active Pharma Sciences Limited, this product is identified by NDC 72643-032.

Identification & Billing

NDC Package Code
72643-032-03
Package Description
10 kg in 1 DRUM
Product Code
72643-032
11-Digit Billing Format
72643003203

Clinical Specifications

Proprietary Name
Pentoxifylline
Non-Proprietary Name
Pentoxifylline
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
Solara Active Pharma Sciences Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
02-02-2023
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (72643-032). Click a package code to view its specific billing and regulatory data.

72643-032-04
25 kg in 1 DRUM
72643-032-05
50 kg in 1 DRUM

* 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 72643-032-03 identifies a specific commercial package of 10 kg in 1 drum of Pentoxifylline (UNFINISHED drug), a bulk ingredient labeled by Solara Active Pharma Sciences Limited. 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 Solara Active Pharma Sciences Limited on February 02, 2023. The current certification is valid through December 31, 2027.

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 Solara Active Pharma Sciences Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72643003203. 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 (5-3-2)
72643-032-03
11-Digit CMS (5-4-2)
72643-0032-03

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