Bismuth Subsalicylate
NDC Package 36800-710-24

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Bismuth Subsalicylate is  swallow with water, do not chew adults and children 12 years and over: 2 softgels every ½ hour or 4 softgels every hour as needed for diarrhea  2 softgels every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)  do not exceed 8 doses (16 softgels) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a doctor drink plenty of clear fluids to help prevent dehydration caused by diarrhea. Marketed by Topco Associates Llc, this product is identified by NDC 36800-710 and is authorized under FDA application M008.

Identification & Billing

NDC Package Code
36800-710-24
Package Description
2 BLISTER PACK in 1 CARTON / 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK
Product Code
36800-710
11-Digit Billing Format
36800071024
RxNorm Crosswalk
RxCUI: 2121072 - bismuth subsalicylate 262 MG Oral Capsule

Clinical Specifications

Proprietary Name
Bismuth Subsalicylate
Dosage Form
-
Usage Information
 swallow with water, do not chew adults and children 12 years and over: 2 softgels every ½ hour or 4 softgels every hour as needed for diarrhea  2 softgels every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)  do not exceed 8 doses (16 softgels) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a doctor drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Regulatory & Marketing

Labeler Name
Topco Associates Llc
FDA Application #
M008
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-19-2021
Listing Expiration
12-31-2025
Exclude Flag
I
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 36800-710-24 identifies a specific commercial package of 2 blister pack in 1 carton / 12 capsule, gelatin coated in 1 blister pack of Bismuth Subsalicylate, labeled by Topco Associates Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Topco Associates Llc on February 19, 2021. The current certification is valid through December 31, 2025.

How is this Topco Associates Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800071024. 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)
36800-710-24
11-Digit CMS (5-4-2)
36800-0710-24

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