Pentosan Polysulfte Sodium Powder
NDC Package 42897-001-01

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.

Pentosan Polysulfte Sodium powders is a medication used to treat pain/discomfort from a certain bladder disorder (interstitial cystitis). This formulation utilizes a powder delivery system. Marketed by Bene Pharmachem Gmbh & Co. Kg, this product is identified by NDC 42897-001.

Identification & Billing

NDC Package Code
42897-001-01
Package Description
50 kg in 1 DRUM
Product Code
42897-001
11-Digit Billing Format
42897000101

Clinical Specifications

Proprietary Name
Pentosan Polysulfte Sodium
Non-Proprietary Name
Pentosan Polysulfte Sodium
Substance Name
Pentosan Polysulfate Sodium
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)
PENTOSAN POLYSULFATE SODIUM 1 kg/kg
Usage Information
This medication is used to treat pain/discomfort from a certain bladder disorder (interstitial cystitis). It may work by forming a layer on the bladder wall and protecting it from harmful/irritating substances in the urine. It is also a weak "blood thinner" and therefore may increase the risk of bruising/bleeding (such as bleeding from the nose/gums).

Regulatory & Marketing

Labeler Name
Bene Pharmachem Gmbh & Co. Kg
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
11-26-1996
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 42897-001-01 identifies a specific commercial package of 50 kg in 1 drum of Pentosan Polysulfte Sodium (UNFINISHED drug), a bulk ingredient labeled by Bene Pharmachem Gmbh & Co. Kg. This powder is formulated for use and contains pentosan polysulfate sodium 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 Bene Pharmachem Gmbh & Co. Kg on November 26, 1996. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat pain/discomfort from a certain bladder disorder (interstitial cystitis). It may work by forming a layer on the bladder wall and protecting it from harmful/irritating substances in the urine. It is also a weak "blood thinner" and therefore may increase the risk of bruising/bleeding (such as bleeding from the nose/gums).

How is this Bene Pharmachem Gmbh & Co. Kg product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42897000101. 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)
42897-001-01
11-Digit CMS (5-4-2)
42897-0001-01

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