FDA.reportPublic FDA data

dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG Oral Capsule

RxCUI
1040054
RxNorm name
dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG Oral Capsule
Display name
Dextromethorphan/quiNIDine (Oral Pill)
Full name
dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG Oral Capsule
Term type
SCD
Status
Active
Strength
20-10 mg
Dose form
Cap
Route
Oral Pill
Updated
2026-06-12 07:01:59

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
122010
Active start
122010
Multiple ingredient
YES
Branded
NO

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_STRdextromethorphan hydrobromide 20 MG / quiNIDine sulfate 10 MG Oral Capsule1NAMES
RxNorm Namedextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG Oral Capsule1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID7028dcb7-f436-4cf6-9beb-23c1d215c7981CODES
RxCUI10400541CODES
MMSL_CODECD266021CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
31722-693-6031722-693Dextromethorphan hydrobromide and quinidine sulfate Dextromethorphan hydrobromide and quinidine sulfateCamber Pharmaceuticals, Inc.ANDA218426

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA21842631722-693Dextromethorphan hydrobromide and quinidine sulfate Dextromethorphan hydrobromide and quinidine sulfateANDACamber Pharmaceuticals, Inc.

RxNav Current And Historical NDCs#

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

NDC11, Source, Active table
NDC11SourceActive
31722069360rxnav_ndcsyes

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dextromethorphan Hydrobromide and Quinidine SulphateDEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULPHATEGolden State Medical Supply, Inc.583de7bd-9b82-5e55-e063-6294a90a0bdf2026-08-04Warnings, Adverse reactionsExact identifier
rxcui: 1040054
Dextromethorphan Hydrobromide and Quinidine SulphateDEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULPHATESun Pharmaceutical Industries, Inc.92b54ac4-594e-47b8-a4d3-394a29b425f32026-07-08Warnings, Adverse reactionsExact identifier
rxcui: 1040054
NuedextaDEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATEOtsuka America Pharmaceutical, Incc8cce784-8c5f-415b-8068-76e5d481d1592026-01-22Warnings, Adverse reactionsExact identifier
rxcui: 1040054
NUEDEXTADEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATEAvanir Pharmaceuticals, Inc.484e0918-3442-49dc-8ccf-177f1f3ee9f32025-10-21Warnings, Adverse reactionsExact identifier
rxcui: 1040054
Dextromethorphan hydrobromide and quinidine sulfateDEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATECamber Pharmaceuticals, Inc.7028dcb7-f436-4cf6-9beb-23c1d215c7982025-02-03Warnings, Adverse reactionsExact identifier
ndc (package): 31722-693-60
ndc (product): 31722-693
ndc11 (package): 31722069360
rxcui: 1040054

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
484e0918-3442-49dc-8ccf-177f1f3ee9f3dextromethorphan HBr 20 MG / quiNIDine sulfate 10 MG Oral Capsule [PSN] · dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG Oral Capsule [SCD]229These 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-8068-76e5d481d159dextromethorphan HBr 20 MG / quiNIDine sulfate 10 MG Oral Capsule [PSN] · dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG Oral Capsule [SCD]24These 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
7028dcb7-f436-4cf6-9beb-23c1d215c798dextromethorphan HBr 20 MG / quiNIDine sulfate 10 MG Oral Capsule [PSN] · dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG Oral Capsule [SCD]21These highlights do not include all the information needed to use DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE CAPSULES safely and effectively. See full prescribing information for DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE CAPSULES. DEXTROMETHORPHAN HYDROBROMIDE and QUINIDINE SULFATE capsules, for oral use Initial U.S. Approval: 201020250203

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
7028dcb7-f436-4cf6-9beb-23c1d215c798These highlights do not include all the information needed to use DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE CAPSULES safely and effectively. See full prescribing information for DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE CAPSULES. DEXTROMETHORPHAN HYDROBROMIDE and QUINIDINE SULFATE capsules, for oral use Initial U.S. Approval: 2010Camber Pharmaceuticals, Inc. | Hetero Labs Limited Unit III20250203

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
CODESANDAANDA218426
CODESVUID4030455
NAMESPrescribable Synonymdextromethorphan HBr 20 MG / quiNIDine sulfate 10 MG Oral Capsule
NAMESTallman Synonymdextromethorphan hydrobromide 20 MG / quiNIDine sulfate 10 MG Oral Capsule
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File