Gentle Laxative Bisacodyl Suppository
NDC Package 13709-321-01

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

Package Information

Gentle Laxative Bisacodyl suppositories is bisacodyl is used to treat constipation. This formulation utilizes a suppository delivery system. Marketed by Neilmed Pharmaceuticals Inc, this product is identified by NDC 13709-321 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
13709-321-01
Package Description
5 BLISTER PACK in 1 CARTON / 6 CAPSULE in 1 BLISTER PACK / 1 SUPPOSITORY in 1 CAPSULE
Product Code
13709-321
11-Digit Billing Format
13709032101
RxNorm Crosswalk
RxCUI: 198509 - bisacodyl 10 MG Rectal Suppository

Clinical Specifications

Proprietary Name
Gentle Laxative Bisacodyl
Non-Proprietary Name
Gentle Laxative Bisacodyl
Substance Name
Bisacodyl
Dosage Form
Suppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.
Administration Route
Rectal - Administration to the rectum.
Active Ingredient(s)
BISACODYL 10 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
Neilmed Pharmaceuticals Inc
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-24-2023
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 13709-321-01 identifies a specific commercial package of 5 blister pack in 1 carton / 6 capsule in 1 blister pack / 1 suppository in 1 capsule of Gentle Laxative Bisacodyl, a human over the counter drug labeled by Neilmed Pharmaceuticals Inc. This suppository is formulated for rectal 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 Neilmed Pharmaceuticals Inc on August 24, 2023. 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 Neilmed Pharmaceuticals Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13709032101. 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)
13709-321-01
11-Digit CMS (5-4-2)
13709-0321-01

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