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NDC 00025-0061-31 Lomotil .025; 2.5 mg/1; mg/1 Details

Lomotil .025; 2.5 mg/1; mg/1

Lomotil is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE.

MedlinePlus Drug Summary

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.

Related Packages: 00025-0061-31
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenoxylate

Product Information

NDC	00025-0061
Product ID	0025-0061_95594203-bf78-4e64-9bc1-0c39429cfc54
Associated GPIs	47100010100310
GCN Sequence Number	002841
GCN Sequence Number Description	diphenoxylate HCl/atropine TABLET 2.5-.025MG ORAL
HIC3	D6D
HIC3 Description	ANTIDIARRHEALS
GCN	65030
HICL Sequence Number	001235
HICL Sequence Number Description	DIPHENOXYLATE HCL/ATROPINE SULFATE
Brand/Generic	Brand
Proprietary Name	Lomotil
Proprietary Name Suffix	n/a
Non-Proprietary Name	diphenoxylate hydrochloride and atropine sulfate
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	.025; 2.5
Active Ingredient Units	mg/1; mg/1
Substance Name	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Labeler Name	Pfizer Laboratories Div Pfizer Inc
Pharmaceutical Class	Anticholinergic [EPC], Antidiarrheal [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
DEA Schedule	CV
Marketing Category	NDA
Application Number	NDA012462
Listing Certified Through	2024-12-31

Package

NDC 00025-0061-31 (00025006131)

Pricing Information	N/A
NDC Package Code	0025-0061-31
Billing NDC	00025006131
Package	100 TABLET in 1 BOTTLE (0025-0061-31)
Marketing Start Date	1960-09-15
NDC Exclude Flag	N