FDA.reportPublic FDA data

dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG Oral Capsule [Nuedexta]

RxCUI
1040058
RxNorm name
dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG Oral Capsule [Nuedexta]
Display name
NUEDEXTA (Oral Pill)
Full name
dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG Oral Capsule [Nuedexta]
Term type
SBD
Status
Active
Strength
20-10 mg
Dose form
Cap
Route
Oral Pill
Updated
2026-06-12 07:02:07

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
122010
Active start
122010
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
dextromethorphan hydrobromide20 MG / 1 EACHdextromethorphandextromethorphan hydrobromide
quinidine sulfate10 MG / 1 EACHquinidinequinidine sulfate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Capsule316965

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
dextromethorphan3289
quinidine9068

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRNuedexta (dextromethorphan hydrobromide 20 MG / quiNIDine sulfate 10 MG) Oral Capsule1NAMES
RxNorm Namedextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG Oral Capsule [Nuedexta]1NAMES
RxNorm SynonymNuedexta (dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG) Oral Capsule1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI10400581CODES
MMSL_CODEBD266021CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
59148-053-1659148-053Nuedexta dextromethorphan hydrobromide and quinidine sulfateOtsuka America Pharmaceutical, IncNDA021879
59148-053-9859148-053Nuedexta dextromethorphan hydrobromide and quinidine sulfateOtsuka America Pharmaceutical, IncNDA021879
64597-301-1364597-301NUEDEXTA dextromethorphan hydrobromide and quinidine sulfateAvanir Pharmaceuticals, Inc.NDA021879
64597-301-6064597-301NUEDEXTA dextromethorphan hydrobromide and quinidine sulfateAvanir Pharmaceuticals, Inc.NDA021879

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA02187959148-053Nuedexta dextromethorphan hydrobromide and quinidine sulfateNDAOtsuka America Pharmaceutical, Inc

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 7 matching rows.

NDC11, Source, Active table
NDC11SourceActive
59148005307rxnav_ndcsyes
59148005316rxnav_ndcsyes
59148005398rxnav_ndcsyes
64597030113rxnav_ndcsyes
64597030160rxnav_ndcsyes
64597001113rxnav_historical
64597001160rxnav_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
NuedextaDEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATEOtsuka America Pharmaceutical, Incc8cce784-8c5f-415b-8068-76e5d481d1592026-01-22Warnings, Adverse reactionsExact identifier
ndc (package): 59148-053-98
ndc (package): 59148-053-16
ndc (product): 59148-053
ndc11 (package): 59148005307
ndc11 (package): 59148005398
ndc11 (package): 59148005316
rxcui: 1040058
NUEDEXTADEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATEAvanir Pharmaceuticals, Inc.484e0918-3442-49dc-8ccf-177f1f3ee9f32025-10-21Warnings, Adverse reactionsExact identifier
ndc (package): 64597-301-60
ndc (package): 64597-301-13
ndc (product): 64597-301
ndc11 (package): 64597030113
ndc11 (package): 64597030160
rxcui: 1040058

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
484e0918-3442-49dc-8ccf-177f1f3ee9f3NUEDEXTA 20 MG / 10 MG Oral Capsule [PSN] · dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG Oral Capsule [Nuedexta] [SBD] · Nuedexta (dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG) Oral Capsule [SY]329These highlights do not include all the information needed to use NUEDEXTA safely and effectively. See full prescribing information for NUEDEXTA. NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules, for oral use Initial U.S. Approval: 201020251021
c8cce784-8c5f-415b-8068-76e5d481d159NUEDEXTA 20 MG / 10 MG Oral Capsule [PSN] · dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG Oral Capsule [Nuedexta] [SBD] · Nuedexta (dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG) Oral Capsule [SY]34These highlights do not include all the information needed to use NUEDEXTA safely and effectively. See full prescribing information for NUEDEXTA. NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules, for oral use Initial U.S. Approval: 201020260122

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
c8cce784-8c5f-415b-8068-76e5d481d159These highlights do not include all the information needed to use NUEDEXTA safely and effectively. See full prescribing information for NUEDEXTA. NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules, for oral use Initial U.S. Approval: 2010Otsuka America Pharmaceutical, Inc20260122
484e0918-3442-49dc-8ccf-177f1f3ee9f3These highlights do not include all the information needed to use NUEDEXTA safely and effectively. See full prescribing information for NUEDEXTA. NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules, for oral use Initial U.S. Approval: 2010Avanir Pharmaceuticals, Inc. | Patheon | Patheon Inc.20251021
484e0918-3442-49dc-8ccf-177f1f3ee9f3These highlights do not include all the information needed to use NUEDEXTA safely and effectively. See full prescribing information for NUEDEXTA. NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules, for oral use Initial U.S. Approval: 2010Avanir Pharmaceuticals, Inc. | Patheon | Patheon Inc.20231201
cdcc20c8-db29-43c9-aef2-f105e5b58878National Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCC01BAAntiarrhythmics, class IaATC1-4quinidine
ATCR05DAOpium alkaloids and derivativesATC1-4dextromethorphan
FDASPLN0000175426AntiarrhythmicEPChas_epcquinidine
FDASPLN0000182135Cytochrome P450 2D6 InhibitorEPChas_epcquinidine
FDASPLN0000182149Sigma-1 AgonistEPChas_epcdextromethorphan
FDASPLN0000181821Uncompetitive N-methyl-D-aspartate Receptor AntagonistEPChas_epcdextromethorphan
FDASPLN0000182137Cytochrome P450 2D6 InhibitorsMOAhas_moaquinidine
FDASPLN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan
FDASPLN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan
MEDRTD002219CarbamatesCHEMci_chemclassquinidine
MEDRTD002219CarbamatesCHEMci_chemclassquinidine sulfate
MEDRTD020117CisaprideCHEMci_chemclassquinidine sulfate
MEDRTD020117CisaprideCHEMci_chemclassquinidine
MEDRTD003915DextromethorphanCHEMhas_ingredientdextromethorphan hydrobromide
MEDRTD003915DextromethorphanCHEMhas_ingredientdextromethorphan
MEDRTD005663FuransCHEMci_chemclassquinidine
MEDRTD005663FuransCHEMci_chemclassquinidine sulfate
MEDRTD011802QuinidineCHEMhas_ingredientquinidine sulfate
MEDRTD011802QuinidineCHEMhas_ingredientquinidine
MEDRTD015363QuinolonesCHEMci_chemclassquinidine
MEDRTD015363QuinolonesCHEMci_chemclassquinidine sulfate
MEDRTD019438RitonavirCHEMci_chemclassquinidine
MEDRTD019438RitonavirCHEMci_chemclassquinidine sulfate
MEDRTD013449SulfonamidesCHEMci_chemclassquinidine sulfate
MEDRTD013449SulfonamidesCHEMci_chemclassquinidine
MEDRTD001281Atrial FibrillationDISEASEmay_treatquinidine sulfate
MEDRTD001281Atrial FibrillationDISEASEmay_treatquinidine
MEDRTD001282Atrial FlutterDISEASEmay_treatquinidine sulfate
MEDRTD001282Atrial FlutterDISEASEmay_treatquinidine
MEDRTD003371CoughDISEASEmay_treatdextromethorphan hydrobromide
MEDRTD003371CoughDISEASEmay_preventdextromethorphan hydrobromide
MEDRTD003371CoughDISEASEmay_preventdextromethorphan
MEDRTD003371CoughDISEASEmay_treatdextromethorphan
MEDRTD004342Drug HypersensitivityDISEASEci_withquinidine
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan hydrobromide
MEDRTD004342Drug HypersensitivityDISEASEci_withquinidine sulfate
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan
MEDRTD006327Heart BlockDISEASEci_withquinidine
MEDRTD006327Heart BlockDISEASEci_withquinidine sulfate
MEDRTD016778Malaria, FalciparumDISEASEmay_preventquinidine
MEDRTD016778Malaria, FalciparumDISEASEmay_preventquinidine sulfate
MEDRTD009157Myasthenia GravisDISEASEci_withquinidine
MEDRTD009157Myasthenia GravisDISEASEci_withquinidine sulfate
MEDRTD011696Purpura, ThrombocytopenicDISEASEci_withquinidine sulfate
MEDRTD011696Purpura, ThrombocytopenicDISEASEci_withquinidine
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_preventquinidine sulfate
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_preventquinidine
MEDRTD017180Tachycardia, VentricularDISEASEmay_preventquinidine
MEDRTD017180Tachycardia, VentricularDISEASEmay_preventquinidine sulfate
MEDRTD018754Ventricular DysfunctionDISEASEci_withquinidine
MEDRTD018754Ventricular DysfunctionDISEASEci_withquinidine sulfate
MEDRTN0000000140Calcium Channel InteractionsMOAhas_moaquinidine
MEDRTN0000000140Calcium Channel InteractionsMOAhas_moaquinidine sulfate
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moadextromethorphan hydrobromide
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moadextromethorphan
MEDRTN0000000211Potassium Channel InteractionsMOAhas_moaquinidine
MEDRTN0000000211Potassium Channel InteractionsMOAhas_moaquinidine sulfate
MEDRTN0000000109Serotonin Uptake InhibitorsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000000109Serotonin Uptake InhibitorsMOAhas_moadextromethorphan
MEDRTN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moaquinidine sulfate
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moaquinidine
MEDRTN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan
MEDRTN0000008330Cardiac Rhythm AlterationPEhas_pequinidine
MEDRTN0000008330Cardiac Rhythm AlterationPEhas_pequinidine sulfate
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pedextromethorphan hydrobromide
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pedextromethorphan

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH20 MG / 10 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA021879
NAMESPrescribable SynonymNUEDEXTA 20 MG / 10 MG Oral Capsule
NAMESTallman Synonymdextromethorphan hydrobromide 20 MG / quiNIDine sulfate 10 MG Oral Capsule [Nuedexta]
NAMESTallman SynonymNuedexta (dextromethorphan hydrobromide 20 MG / quiNIDine sulfate 10 MG) Oral Capsule
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon