Prucalopride Succinate Tablet
NDC Package 70069-821-01

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

Package Information

Prucalopride Succinate tablets is a medication used to treat chronic constipation. This formulation utilizes a tablet delivery system. Marketed by Somerset Therapeutics, Llc, this product is identified by NDC 70069-821 and is authorized under FDA application ANDA219078.

Identification & Billing

NDC Package Code
70069-821-01
Package Description
1 BOTTLE in 1 BOTTLE / 30 TABLET in 1 BOTTLE
Product Code
70069-821
11-Digit Billing Format
70069082101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Prucalopride Succinate
Non-Proprietary Name
Prucalopride Succinate
Substance Name
Prucalopride Succinate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PRUCALOPRIDE SUCCINATE 1 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat chronic constipation. It is used when other medications used to treat constipation (such as laxatives) have not provided relief. Prucalopride works by improving how well your stomach and intestines move food through the bowels during digestion.

Regulatory & Marketing

Labeler Name
Somerset Therapeutics, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA219078
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-24-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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 70069-821-01 identifies a specific commercial package of 1 bottle in 1 bottle / 30 tablet in 1 bottle of Prucalopride Succinate, a human prescription drug labeled by Somerset Therapeutics, Llc. This tablet is formulated for oral use and contains prucalopride succinate 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 Somerset Therapeutics, Llc on June 24, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat chronic constipation. It is used when other medications used to treat constipation (such as laxatives) have not provided relief. Prucalopride works by improving how well your stomach and intestines move food through the bowels during digestion.

How is this Somerset Therapeutics, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70069082101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
70069-821-01
11-Digit CMS (5-4-2)
70069-0821-01

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