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  5. NDC Package Code: 0781-8158-31 Prucalopride

NDC Package 0781-8158-31 Prucalopride

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0781-8158-31
Package Description:
30 TABLET, FILM COATED in 1 BOTTLE
Product Code:
0781-8158
Proprietary Name:
Prucalopride
Non-Proprietary Name:
Prucalopride
Substance Name:
Prucalopride Succinate
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.
11-Digit NDC Billing Format:
00781815831
Product Type:
Human Prescription Drug
Labeler Name:
Sandoz Inc.
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
PRUCALOPRIDE SUCCINATE 1 mg/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA218963
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
06-13-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 0781-8158-31?

The NDC Packaged Code 0781-8158-31 is assigned to a package of 30 tablet, film coated in 1 bottle of Prucalopride, a human prescription drug labeled by Sandoz Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

Is NDC 0781-8158 included in the NDC Directory?

Yes, Prucalopride with product code 0781-8158 is active and included in the NDC Directory. The product was first marketed by Sandoz Inc. on June 13, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 0781-8158-31?

The 11-digit format is 00781815831. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
4-4-20781-8158-315-4-200781-8158-31