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NDC 0025-0061 Lomotil

Diphenoxylate Hydrochloride And Atropine Sulfate Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0025-0061?
  5. Lomotil Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Get all the details for National Drug Code (NDC) 0025-0061 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
0025-0061
Proprietary Name:
Lomotil
Non-Proprietary Name: [1]
Diphenoxylate Hydrochloride And Atropine Sulfate
Substance Name: [2]
Atropine Sulfate; Diphenoxylate Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler Name: [5]
Pfizer Laboratories Div Pfizer Inc
Labeler Code:
0025
Product Label ID:
f170584a-1072-4fd7-b1dc-6756703483b9
FDA Application Number: [6]
NDA012462
DEA Schedule: [7]
Schedule V (CV) Substances
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
09-15-1960
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
6 MM
Imprint(s):
SEARLE;61
Score:
1

Code Structure Chart

Product Details

What is NDC 0025-0061?

The NDC code 0025-0061 is assigned by the FDA to the product Lomotil which is a human prescription drug product labeled by Pfizer Laboratories Div Pfizer Inc. The generic name of Lomotil is diphenoxylate hydrochloride and atropine sulfate. The product's dosage form is tablet and is administered via oral form. The product is distributed in a single package with assigned NDC code 0025-0061-31 100 tablet in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Lomotil?

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).

What are Lomotil Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ATROPINE SULFATE .025 mg/1 - An alkaloid, originally from Atropa belladonna, but found in other plants, mainly SOLANACEAE. Hyoscyamine is the 3(S)-endo isomer of atropine.
  • DIPHENOXYLATE HYDROCHLORIDE 2.5 mg/1 - A MEPERIDINE congener used as an antidiarrheal, usually in combination with ATROPINE. At high doses, it acts like morphine. Its unesterified metabolite difenoxin has similar properties and is used similarly. It has little or no analgesic activity.

Which are Lomotil UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Lomotil Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Lomotil?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

Which are the Pharmacologic Classes for Lomotil?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Patient Education

Diphenoxylate


Diphenoxylate is used along with other treatments such as fluid and electrolyte replacement for the treatment of diarrhea. Diphenoxylate should not be given to children younger than 2 years of age. Diphenoxylate is in a class of medications called antidiarrheal agents. It works by decreasing activity of the bowel.
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* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[7] What is the Drug Enforcement Administration (DEA) CV Schedule? - This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".