Pepto-bismol Tablet
NDC Package 76420-490-24

11-digit billing NDC: 76420049024
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Pepto-bismol (bismuth subsalicylate) tablets is • swallow with water, do not chew • adults and children 12 years and over: 2 caplets (1 dose) every ½ hour or 4 caplets (2 doses) every hour as needed for diarrhea2 caplets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)• do not exceed 8 doses (16 caplets) 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. This formulation utilizes a tablet delivery system. Marketed by Asclemed Usa Inc., this product is identified by NDC 76420-490 and is authorized under FDA application M008.

Identification & Billing

NDC Package Code
76420-490-24
Package Description
1 BOTTLE in 1 CARTON / 24 TABLET in 1 BOTTLE
Product Code
76420-490
11-Digit Billing Format
76420049024
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pepto-bismol
Non-Proprietary Name
Bismuth Subsalicylate
Substance Name
Bismuth Subsalicylate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BISMUTH SUBSALICYLATE 262 mg/1
Usage Information
• swallow with water, do not chew • adults and children 12 years and over: 2 caplets (1 dose) every ½ hour or 4 caplets (2 doses) every hour as needed for diarrhea2 caplets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)• do not exceed 8 doses (16 caplets) 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
Asclemed Usa Inc.
Product Type
Human Otc Drug
FDA Application #
M008
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-30-2004
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 76420-490-24 identifies a specific commercial package of 1 bottle in 1 carton / 24 tablet in 1 bottle of Pepto-bismol, a human over the counter drug labeled by Asclemed Usa Inc.. This tablet is formulated for oral use and contains bismuth subsalicylate 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 Asclemed Usa Inc. on June 30, 2004. The current certification is valid through December 31, 2026.

How is this Asclemed Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76420049024. 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)
76420-490-24
11-Digit CMS (5-4-2)
76420-0490-24

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