Gentle Laxative Tablet, Delayed Release
NDC Package 41163-607-52

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

Package Information

Gentle Laxative (bisacodyl) tablets is bisacodyl is used to treat constipation. This formulation utilizes a tablet, delayed release delivery system. Marketed by United Natural Foods, Inc. Dba Unfi, this product is identified by NDC 41163-607 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
41163-607-52
Package Description
5 BLISTER PACK in 1 CARTON / 18 TABLET, DELAYED RELEASE in 1 BLISTER PACK
Product Code
41163-607
11-Digit Billing Format
41163060752
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
5 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Gentle Laxative
Non-Proprietary Name
Bisacodyl
Substance Name
Bisacodyl
Dosage Form
Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BISACODYL 5 mg/1
Pharmacologic Class
Usage Information
Bisacodyl is used to treat constipation. It may also be used to clean out the intestines before a bowel examination/surgery. Bisacodyl is known as a stimulant laxative. It works by increasing the movement of the intestines, helping the stool to come out.

Regulatory & Marketing

Labeler Name
United Natural Foods, Inc. Dba Unfi
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-01-2013
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (41163-607). Click a package code to view its specific billing and regulatory data.

41163-607-56
1 BLISTER PACK in 1 CARTON / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK

* 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 41163-607-52 identifies a specific commercial package of 5 blister pack in 1 carton / 18 tablet, delayed release in 1 blister pack of Gentle Laxative, a human over the counter drug labeled by United Natural Foods, Inc. Dba Unfi. This product is billed for "EA" each discreet unit and contains an estimated amount of 5 billable units per package. This tablet, delayed release is formulated for oral use and contains bisacodyl 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 United Natural Foods, Inc. Dba Unfi on April 01, 2013. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Bisacodyl is used to treat constipation. It may also be used to clean out the intestines before a bowel examination/surgery. Bisacodyl is known as a stimulant laxative. It works by increasing the movement of the intestines, helping the stool to come out.

How is this United Natural Foods, Inc. Dba Unfi product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 41163060752. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 5 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)
41163-607-52
11-Digit CMS (5-4-2)
41163-0607-52

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