Prucalopride Tablet, Film Coated
NDC Package 70771-1900-3

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

Package Information

Prucalopride tablets is a medication used to treat chronic constipation. This formulation utilizes a tablet, film coated delivery system. Marketed by Zydus Lifesciences Limited, this product is identified by NDC 70771-1900 and is authorized under FDA application ANDA218056.

Identification & Billing

NDC Package Code
70771-1900-3
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
70771-1900
11-Digit Billing Format
70771190003
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Prucalopride
Non-Proprietary Name
Prucalopride
Substance Name
Prucalopride Succinate
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PRUCALOPRIDE SUCCINATE 2 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
Zydus Lifesciences Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA218056
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-02-2026
Listing Expiration
12-31-2027
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 70771-1900-3 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Prucalopride, a human prescription drug labeled by Zydus Lifesciences Limited. This tablet, film coated 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 Zydus Lifesciences Limited on February 02, 2026. The current certification is valid through December 31, 2027.

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 Zydus Lifesciences Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70771190003. 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)
70771-1900-3
11-Digit CMS (5-4-2)
70771-1900-03

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