MedPath

Diphenoxylate

Generic Name
Diphenoxylate
Brand Names
Lomotil
Drug Type
Small Molecule
Chemical Formula
C30H32N2O2
CAS Number
915-30-0
Unique Ingredient Identifier
73312P173G

Overview

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. This medication is classified as a Schedule V under the Controlled Substances Act by the Food and Drug Administration (FDA) and the DEA in the United States when used in preparations. When diphenoxylate is used alone, it is classified as a Schedule II.

Background

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. This medication is classified as a Schedule V under the Controlled Substances Act by the Food and Drug Administration (FDA) and the DEA in the United States when used in preparations. When diphenoxylate is used alone, it is classified as a Schedule II.

Indication

For as adjunctive therapy in the management of diarrhea

Associated Conditions

  • Diarrhea

FDA Approved Products

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Manufacturer:RedPharm Drug, Inc.
Route:ORAL
Strength:2.5 mg in 1 1
Approved: 2019/01/01
NDC:67296-1675
Diphenoxylate Hydrochloride and Atropine Sulfate
Manufacturer:Bryant Ranch Prepack
Route:ORAL
Strength:2.5 mg in 1 1
Approved: 2024/02/01
NDC:72162-1765
Diphenoxylate Hydrochloride and Atropine Sulfate
Manufacturer:Hikma Pharmaceuticals USA Inc.
Route:ORAL
Strength:2.5 mg in 5 mL
Approved: 2023/04/24
NDC:0054-3194
Diphenoxylate Hydrochloride and Atropine Sulfate
Manufacturer:Aphena Pharma Solutions - Tennessee, LLC
Route:ORAL
Strength:2.5 mg in 1 1
Approved: 2024/03/28
NDC:71610-809
Diphenoxylate Hydrochloride and Atropine Sulfate
Manufacturer:Proficient Rx LP
Route:ORAL
Strength:2.5 mg in 1 1
Approved: 2022/03/01
NDC:71205-909

Singapore Approved Products

SUN-DIANOX TABLET
Manufacturer:SUNWARD PHARMACEUTICAL PRIVATE LIMITED, Sunward Pharmaceutical Sdn. Bhd.
Form:TABLET
Strength:2.5 mg
Online:Yes
Approved: 1996/12/20
Approval:SIN09095P
DHAMOTIL TABLET
Manufacturer:BEACONS PHARMACEUTICALS PTE. LTD.
Form:TABLET, FILM COATED
Strength:2.5 mg
Online:Yes
Approved: 1991/01/29
Approval:SIN05379P

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