FDA.reportPublic FDA data

atropine sulfate 0.025 MG / difenoxin hydrochloride 1 MG Oral Tablet [Motofen]

RxCUI
1190740
RxNorm name
atropine sulfate 0.025 MG / difenoxin hydrochloride 1 MG Oral Tablet [Motofen]
Display name
MOTOFEN (Oral Pill)
Full name
atropine sulfate 0.025 MG / difenoxin hydrochloride 1 MG Oral Tablet [Motofen]
Term type
SBD
Status
Active
Strength
0.025-1 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-08-08 11:34:10

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
112011
Active start
112011
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
atropine sulfate0.025 MG / 1 EACHatropineatropine sulfate
difenoxin hydrochloride1 MG / 1 EACHdifenoxindifenoxin

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
atropine1223
difenoxin23024

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRMotofen (atropine sulfate 0.025 MG / difenoxin hydrochloride 1 MG) Oral Tablet1NAMES
RxNorm Nameatropine sulfate 0.025 MG / difenoxin hydrochloride 1 MG Oral Tablet [Motofen]1NAMES
RxNorm SynonymMotofen (atropine sulfate 0.025 MG / difenoxin hydrochloride 1 MG) Oral Tablet1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI11907401CODES
MMSL_CODEBD37671CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
54766-200-1054766-200Motofen difenoxin and atropine sulfateSebela Pharmaceuticals Inc.NDA017744
83107-011-1083107-011Motofen difenoxin and atropine sulfateLegacy Pharma USA Inc.NDA017744

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA01774454766-200Motofen difenoxin and atropine sulfateNDASebela Pharmaceuticals Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 15 matching rows.

NDC11, Source, Active table
NDC11SourceActive
54766020004rxnav_ndcsyes
54766020010rxnav_ndcsyes
83107001110rxnav_ndcsyes
00086007405rxnav_historical_indirect
00086007410rxnav_historical_indirect
00143903105rxnav_historical
00143903110rxnav_historical
00187050001rxnav_historical
00187050002rxnav_historical
54868351000rxnav_historical
54868351001rxnav_historical
55045277100rxnav_historical
65234007402rxnav_historical
65234007405rxnav_historical
65234007410rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MotofenDIFENOXIN AND ATROPINE SULFATELegacy Pharma USA Inc.1fa11c67-5492-469c-9475-6bfa0e5e9ff82026-03-23Warnings, Adverse reactionsExact identifier
ndc (package): 83107-011-10
ndc (product): 83107-011
ndc11 (package): 83107001110
rxcui: 1190740
MotofenDIFENOXIN AND ATROPINE SULFATESebela Pharmaceuticals Inc.4cd3f029-a5e3-5812-e054-00144ff8d46c2025-11-08Warnings, Adverse reactionsExact identifier
ndc (package): 54766-200-10
ndc (product): 54766-200
ndc11 (package): 54766020010
ndc11 (package): 54766020004
rxcui: 1190740

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
4cd3f029-a5e3-5812-e054-00144ff8d46cMotofen 1 MG / 0.025 MG Oral Tablet [PSN] · atropine sulfate 0.025 MG / difenoxin hydrochloride 1 MG Oral Tablet [Motofen] [SBD] · Motofen (atropine sulfate 0.025 MG / difenoxin hydrochloride 1 MG) Oral Tablet [SY]34Motofen® (difenoxin and atropine sulfate tablets) CIV Rx Only20251108
1fa11c67-5492-469c-9475-6bfa0e5e9ff8Motofen 1 MG / 0.025 MG Oral Tablet [PSN] · atropine sulfate 0.025 MG / difenoxin hydrochloride 1 MG Oral Tablet [Motofen] [SBD] · Motofen (atropine sulfate 0.025 MG / difenoxin hydrochloride 1 MG) Oral Tablet [SY]32Motofen ® (difenoxin and atropine sulfate tablets) CIV Rx Only20260323

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
1fa11c67-5492-469c-9475-6bfa0e5e9ff8Motofen ® (difenoxin and atropine sulfate tablets) CIV Rx OnlyLegacy Pharma USA Inc.20260323
4cd3f029-a5e3-5812-e054-00144ff8d46cMotofen® (difenoxin and atropine sulfate tablets) CIV Rx OnlySebela Pharmaceuticals Inc. | Alcami Carolinas Corporation20251108
4cd3f029-a5e3-5812-e054-00144ff8d46cMotofen® (difenoxin and atropine sulfate tablets) CIV Rx OnlySebela Pharmaceuticals Inc. | Alcami Carolinas Corporation20181214
e61da078-f517-4c76-b9c8-102078aca25dNational Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCS01FAAnticholinergicsATC1-4atropine
ATCA07DAAntipropulsivesATC1-4difenoxin
ATCA03BABelladonna alkaloids, tertiary aminesATC1-4atropine
FDASPLN0000175574AnticholinergicEPChas_epcatropine
FDASPLN0000178374AntidiarrhealEPChas_epcdifenoxin
FDASPLN0000175700Cholinergic Muscarinic AntagonistEPChas_epcatropine
FDASPLN0000175370Cholinergic AntagonistsMOAhas_moaatropine
FDASPLN0000000125Cholinergic Muscarinic AntagonistsMOAhas_moaatropine
MEDRTD001285AtropineCHEMhas_ingredientatropine sulfate
MEDRTD001285AtropineCHEMhas_ingredientatropine
MEDRTD004157DiphenoxylateCHEMhas_ingredientdifenoxin
MEDRTD004157DiphenoxylateCHEMhas_ingredientdifenoxin hydrochloride
MEDRTD001249AsthmaDISEASEci_withatropine
MEDRTD001249AsthmaDISEASEci_withatropine sulfate
MEDRTD001919BradycardiaDISEASEmay_treatatropine sulfate
MEDRTD001919BradycardiaDISEASEmay_treatatropine
MEDRTD002675Child, PreschoolDISEASEci_withdifenoxin
MEDRTD002675Child, PreschoolDISEASEci_withdifenoxin hydrochloride
MEDRTD003093Colitis, UlcerativeDISEASEci_withatropine sulfate
MEDRTD003093Colitis, UlcerativeDISEASEci_withatropine
MEDRTD003967DiarrheaDISEASEmay_treatdifenoxin
MEDRTD003967DiarrheaDISEASEci_withdifenoxin hydrochloride
MEDRTD003967DiarrheaDISEASEmay_treatdifenoxin hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withdifenoxin hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withatropine sulfate
MEDRTD004342Drug HypersensitivityDISEASEci_withatropine
MEDRTD004342Drug HypersensitivityDISEASEci_withdifenoxin
MEDRTD064420Drug-Related Side Effects and Adverse ReactionsDISEASEmay_treatatropine sulfate
MEDRTD064420Drug-Related Side Effects and Adverse ReactionsDISEASEmay_treatatropine
MEDRTD004405Dysentery, BacillaryDISEASEci_withdifenoxin
MEDRTD004405Dysentery, BacillaryDISEASEci_withdifenoxin hydrochloride
MEDRTD004761Enterocolitis, PseudomembranousDISEASEci_withdifenoxin hydrochloride
MEDRTD004761Enterocolitis, PseudomembranousDISEASEci_withdifenoxin
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withatropine sulfate
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withatropine
MEDRTD006323Heart ArrestDISEASEmay_treatatropine sulfate
MEDRTD006323Heart ArrestDISEASEmay_treatatropine
MEDRTD006327Heart BlockDISEASEci_withatropine sulfate
MEDRTD006327Heart BlockDISEASEci_withatropine
MEDRTD007415Intestinal ObstructionDISEASEci_withatropine
MEDRTD007415Intestinal ObstructionDISEASEci_withatropine sulfate
MEDRTD007499Iris DiseasesDISEASEci_withatropine
MEDRTD007499Iris DiseasesDISEASEci_withatropine sulfate
MEDRTD007565JaundiceDISEASEci_withdifenoxin
MEDRTD007565JaundiceDISEASEci_withdifenoxin hydrochloride
MEDRTD007674Kidney DiseasesDISEASEci_withatropine
MEDRTD007674Kidney DiseasesDISEASEci_withatropine sulfate
MEDRTD007905Lens DiseasesDISEASEci_withatropine
MEDRTD007905Lens DiseasesDISEASEci_withatropine sulfate
MEDRTD008107Liver DiseasesDISEASEci_withatropine
MEDRTD008107Liver DiseasesDISEASEci_withatropine sulfate
MEDRTD008532Megacolon, ToxicDISEASEci_withatropine sulfate
MEDRTD008532Megacolon, ToxicDISEASEci_withatropine
MEDRTD009157Myasthenia GravisDISEASEci_withatropine sulfate
MEDRTD009157Myasthenia GravisDISEASEci_withatropine
MEDRTD015878MydriasisDISEASEinducesatropine
MEDRTD015878MydriasisDISEASEinducesatropine sulfate
MEDRTD011041PoisoningDISEASEmay_treatatropine
MEDRTD011041PoisoningDISEASEmay_treatatropine sulfate
MEDRTD012480Salmonella InfectionsDISEASEci_withdifenoxin
MEDRTD012480Salmonella InfectionsDISEASEci_withdifenoxin hydrochloride
MEDRTD012848Sinoatrial BlockDISEASEmay_treatatropine
MEDRTD012848Sinoatrial BlockDISEASEmay_treatatropine sulfate
MEDRTD013276Stomach UlcerDISEASEmay_treatatropine sulfate
MEDRTD013276Stomach UlcerDISEASEmay_treatatropine
MEDRTD013610TachycardiaDISEASEci_withatropine sulfate
MEDRTD013610TachycardiaDISEASEci_withatropine
MEDRTD013971ThyrotoxicosisDISEASEci_withatropine
MEDRTD013971ThyrotoxicosisDISEASEci_withatropine sulfate
MEDRTD000267Tissue AdhesionsDISEASEci_withatropine
MEDRTD000267Tissue AdhesionsDISEASEci_withatropine sulfate
MEDRTD014517Ureteral ObstructionDISEASEci_withatropine sulfate
MEDRTD014517Ureteral ObstructionDISEASEci_withatropine
MEDRTD014605UveitisDISEASEmay_treatatropine sulfate
MEDRTD014605UveitisDISEASEmay_treatatropine
MEDRTD014987XerostomiaDISEASEinducesatropine sulfate
MEDRTD014987XerostomiaDISEASEinducesatropine
MEDRTN0000000125Cholinergic Muscarinic AntagonistsMOAhas_moaatropine sulfate
MEDRTN0000000125Cholinergic Muscarinic AntagonistsMOAhas_moaatropine
MEDRTN0000000085Receptor InteractionsMOAhas_moadifenoxin
MEDRTN0000000085Receptor InteractionsMOAhas_moadifenoxin hydrochloride
MEDRTN0000008635Decreased GI MotilityPEhas_pedifenoxin hydrochloride
MEDRTN0000008635Decreased GI MotilityPEhas_pedifenoxin
MEDRTN0000008779Decreased Parasympathetic Acetylcholine ActivityPEhas_peatropine
MEDRTN0000008779Decreased Parasympathetic Acetylcholine ActivityPEhas_peatropine sulfate
MEDRTN0000008868Decreased Respiratory SecretionsPEhas_peatropine
MEDRTN0000008868Decreased Respiratory SecretionsPEhas_peatropine sulfate
MEDRTN0000009808Positive ChronotropyPEhas_peatropine
MEDRTN0000009808Positive ChronotropyPEhas_peatropine sulfate
MEDRTN0000009820Pupillary DilationPEhas_peatropine
MEDRTN0000009820Pupillary DilationPEhas_peatropine sulfate
MEDRTN0000009842Salivation InhibitionPEhas_peatropine
MEDRTN0000009842Salivation InhibitionPEhas_peatropine sulfate
MEDRTN0000009870Stimulation Large Intestine Fluid/Electrolyte AbsorptionPEhas_pedifenoxin
MEDRTN0000009870Stimulation Large Intestine Fluid/Electrolyte AbsorptionPEhas_pedifenoxin hydrochloride
MEDRTN0000009874Stimulation Small Intestine Fluid/Electrolyte AbsorptionPEhas_pedifenoxin
MEDRTN0000009874Stimulation Small Intestine Fluid/Electrolyte AbsorptionPEhas_pedifenoxin hydrochloride

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH0.025 MG / 1 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE4
CODESNDANDA017744
NAMESPrescribable SynonymMotofen 1 MG / 0.025 MG Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon