Crofelemer Powder
NDC Package 17359-8750-1

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.

Crofelemer powders is crofelemer is used to relieve symptoms of diarrhea in HIV/AIDS patients who are taking medicines to treat HIV infection. This formulation utilizes a powder delivery system. Marketed by Indena Spa, this product is identified by NDC 17359-8750.

Identification & Billing

NDC Package Code
17359-8750-1
Package Description
5000 g in 1 CONTAINER
Product Code
17359-8750
11-Digit Billing Format
17359875001

Clinical Specifications

Proprietary Name
Crofelemer
Non-Proprietary Name
Crofelemer
Substance Name
Crofelemer
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)
CROFELEMER 1 g/g
Usage Information
Crofelemer is used to relieve symptoms of diarrhea in HIV/AIDS patients who are taking medicines to treat HIV infection. This medication may reduce the number of watery stools you have and help you better tolerate your HIV medications. It works by preventing water and minerals from entering into the intestines, causing the stools to be more solid. Crofelemer should not be used to treat diarrhea caused by infections.

Regulatory & Marketing

Labeler Name
Indena Spa
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
12-18-2023
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 17359-8750-1 identifies a specific commercial package of 5000 g in 1 container of Crofelemer (UNFINISHED drug), a bulk ingredient labeled by Indena Spa. This powder is formulated for use and contains crofelemer 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 Indena Spa on December 18, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Crofelemer is used to relieve symptoms of diarrhea in HIV/AIDS patients who are taking medicines to treat HIV infection. This medication may reduce the number of watery stools you have and help you better tolerate your HIV medications. It works by preventing water and minerals from entering into the intestines, causing the stools to be more solid. Crofelemer should not be used to treat diarrhea caused by infections.

How is this Indena Spa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17359875001. 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)
17359-8750-1
11-Digit CMS (5-4-2)
17359-8750-01

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