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  4. NDC Product Code: 54868-0427 Lomotil

NDC 54868-0427 Lomotil

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54868-0427?
  5. Lomotil Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
54868-0427
Proprietary Name:
Lomotil
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Product Label ID:
d2b171be-ac59-48ec-84da-03d3f2d34ca6
Start Marketing Date: [9]
01-19-2009
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

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

Code Structure Chart

Product Details

What is NDC 54868-0427?

The NDC code 54868-0427 is assigned by the FDA to the product Lomotil which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in 4 packages with assigned NDC codes 54868-0427-0 100 tablet in 1 bottle , 54868-0427-3 30 tablet in 1 bottle , 54868-0427-4 12 tablet in 1 bottle , 54868-0427-5 10 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).

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

* Please review the disclaimer below.

Product Footnotes

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

[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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".