Lomotil Tablet
NDC Package 0025-0061-31

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

Package Information

Lomotil (diphenoxylate hydrochloride and atropine sulfate) tablets is a medication used to treat diarrhea. This formulation utilizes a tablet delivery system. Marketed by Pfizer Laboratories Div Pfizer Inc, this product is identified by NDC 0025-0061 and is authorized under FDA application NDA012462.

Identification & Billing

NDC Package Code
0025-0061-31
Package Description
100 TABLET in 1 BOTTLE
Product Code
0025-0061
11-Digit Billing Format
00025006131
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 1190572 - diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral Tablet
  • RxCUI: 1190572 - atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet
  • RxCUI: 1190641 - Lomotil 2.5 MG / 0.025 MG Oral Tablet
  • RxCUI: 1190641 - atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet [Lomotil]
  • RxCUI: 1190641 - Lomotil (atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG) Oral Tablet

Clinical Specifications

Proprietary Name
Lomotil
Non-Proprietary Name
Diphenoxylate Hydrochloride And Atropine Sulfate
Substance Name
Atropine Sulfate; Diphenoxylate Hydrochloride
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)
Pharmacologic Class
Usage Information
This medication is used to treat diarrhea. It helps to decrease the number and frequency of bowel movements. It works by slowing the movement of the intestines. Diphenoxylate is similar to opioid pain relievers, but it acts mainly to slow the gut. Atropine belongs to a class of drugs known as anticholinergics, which help to dry up body fluids and also slow gut movement. This medication should not be used to treat diarrhea caused by certain types of infection (such as C. difficile-associated diarrhea following antibiotic therapy). Talk to your doctor for more details. This medication is not recommended for use in children younger than 6 years due to an increased risk of serious side effects (such as breathing problems).
DEA Schedule
Schedule V (CV) Substances

Regulatory & Marketing

Labeler Name
Pfizer Laboratories Div Pfizer Inc
Product Type
Human Prescription Drug
FDA Application #
NDA012462
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-15-1960
Listing Expiration
12-31-2027
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 0025-0061-31 identifies a specific commercial package of 100 tablet in 1 bottle of Lomotil, a human prescription drug labeled by Pfizer Laboratories Div Pfizer Inc. This tablet is formulated for oral use and contains atropine sulfate; diphenoxylate hydrochloride 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 Pfizer Laboratories Div Pfizer Inc on September 15, 1960. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat diarrhea. It helps to decrease the number and frequency of bowel movements. It works by slowing the movement of the intestines. Diphenoxylate is similar to opioid pain relievers, but it acts mainly to slow the gut. Atropine belongs to a class of drugs known as anticholinergics, which help to dry up body fluids and also slow gut movement. This medication should not be used to treat diarrhea caused by certain types of infection (such as C. difficile-associated diarrhea following antibiotic therapy). Talk to your doctor for more details. This medication is not recommended for use in children younger than 6 years due to an increased risk of serious side effects (such as breathing problems).

How is this Pfizer Laboratories Div Pfizer Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00025006131. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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 (4-4-2)
0025-0061-31
11-Digit CMS (5-4-2)
00025-0061-31

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