Home RxNorm 1040058 dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG Oral Capsule [Nuedexta] Drug identity information. FDA.report links public drug records from RxNav, DailyMed, FDA NDC, Drugs@FDA, and related public sources where available. This page is informational only and is not medical, prescribing, or regulatory advice.
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# Derived Ingredient Concepts# FDA NDC Products And Packages# Package NDC, Product NDC, Name table Package NDC Product NDC Name Labeler Application 59148-053-16 59148-053 Nuedexta dextromethorphan hydrobromide and quinidine sulfate Otsuka America Pharmaceutical, Inc NDA021879 59148-053-98 59148-053 Nuedexta dextromethorphan hydrobromide and quinidine sulfate Otsuka America Pharmaceutical, Inc NDA021879 64597-301-13 64597-301 NUEDEXTA dextromethorphan hydrobromide and quinidine sulfate Avanir Pharmaceuticals, Inc. NDA021879 64597-301-60 64597-301 NUEDEXTA dextromethorphan hydrobromide and quinidine sulfate Avanir Pharmaceuticals, Inc. NDA021879
Drugs@FDA Applications# Application, NDC, Name table Application NDC Name Marketing category Labeler NDA021879 59148-053 Nuedexta dextromethorphan hydrobromide and quinidine sulfate NDA Otsuka America Pharmaceutical, Inc
RxNav Current And Historical NDCs# NDC11, Source, Active table NDC11 Source Active 59148005307 rxnav_ndcs yes 59148005316 rxnav_ndcs yes 59148005398 rxnav_ndcs yes 64597030113 rxnav_ndcs yes 64597030160 rxnav_ndcs yes 64597001113 rxnav_historical 64597001160 rxnav_historical
DailyMed RxNorm Mappings# Set ID, RxNorm string, TTY table Set ID RxNorm string TTY SPL version Label Effective 484e0918-3442-49dc-8ccf-177f1f3ee9f3 Nuedexta (dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG) Oral Capsule SY 29 These 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: 2010 20251021 484e0918-3442-49dc-8ccf-177f1f3ee9f3 NUEDEXTA 20 MG / 10 MG Oral Capsule PSN 29 These 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: 2010 20251021 484e0918-3442-49dc-8ccf-177f1f3ee9f3 dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG Oral Capsule [Nuedexta] SBD 29 These 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: 2010 20251021 c8cce784-8c5f-415b-8068-76e5d481d159 Nuedexta (dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG) Oral Capsule SY 4 These 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: 2010 20260122 c8cce784-8c5f-415b-8068-76e5d481d159 dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG Oral Capsule [Nuedexta] SBD 4 These 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: 2010 20260122 c8cce784-8c5f-415b-8068-76e5d481d159 NUEDEXTA 20 MG / 10 MG Oral Capsule PSN 4 These 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: 2010 20260122
DailyMed Labels# Set ID, Title, Manufacturer table Set ID Title Manufacturer Effective c8cce784-8c5f-415b-8068-76e5d481d159 These 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: 2010 Otsuka America Pharmaceutical, Inc 20260122 484e0918-3442-49dc-8ccf-177f1f3ee9f3 These 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: 2010 Avanir Pharmaceuticals, Inc. | Patheon | Patheon Inc. 20251021 484e0918-3442-49dc-8ccf-177f1f3ee9f3 These 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: 2010 Avanir Pharmaceuticals, Inc. | Patheon | Patheon Inc. 20231201
Drug Classes# Source, Class ID, Class table Source Class ID Class Type Relationship Drug concept ATC C01BA Antiarrhythmics, class Ia ATC1-4 quinidine ATC R05DA Opium alkaloids and derivatives ATC1-4 dextromethorphan FDASPL N0000175426 Antiarrhythmic EPC has_epc quinidine FDASPL N0000182135 Cytochrome P450 2D6 Inhibitor EPC has_epc quinidine FDASPL N0000182149 Sigma-1 Agonist EPC has_epc dextromethorphan FDASPL N0000181821 Uncompetitive N-methyl-D-aspartate Receptor Antagonist EPC has_epc dextromethorphan FDASPL N0000182137 Cytochrome P450 2D6 Inhibitors MOA has_moa quinidine FDASPL N0000182147 Sigma-1 Receptor Agonists MOA has_moa dextromethorphan FDASPL N0000181819 Uncompetitive NMDA Receptor Antagonists MOA has_moa dextromethorphan MEDRT D002219 Carbamates CHEM ci_chemclass quinidine MEDRT D002219 Carbamates CHEM ci_chemclass quinidine sulfate MEDRT D020117 Cisapride CHEM ci_chemclass quinidine sulfate MEDRT D020117 Cisapride CHEM ci_chemclass quinidine MEDRT D003915 Dextromethorphan CHEM has_ingredient dextromethorphan hydrobromide MEDRT D003915 Dextromethorphan CHEM has_ingredient dextromethorphan MEDRT D005663 Furans CHEM ci_chemclass quinidine MEDRT D005663 Furans CHEM ci_chemclass quinidine sulfate MEDRT D011802 Quinidine CHEM has_ingredient quinidine sulfate MEDRT D011802 Quinidine CHEM has_ingredient quinidine MEDRT D015363 Quinolones CHEM ci_chemclass quinidine MEDRT D015363 Quinolones CHEM ci_chemclass quinidine sulfate MEDRT D019438 Ritonavir CHEM ci_chemclass quinidine MEDRT D019438 Ritonavir CHEM ci_chemclass quinidine sulfate MEDRT D013449 Sulfonamides CHEM ci_chemclass quinidine sulfate MEDRT D013449 Sulfonamides CHEM ci_chemclass quinidine MEDRT D001281 Atrial Fibrillation DISEASE may_treat quinidine sulfate MEDRT D001281 Atrial Fibrillation DISEASE may_treat quinidine MEDRT D001282 Atrial Flutter DISEASE may_treat quinidine sulfate MEDRT D001282 Atrial Flutter DISEASE may_treat quinidine MEDRT D003371 Cough DISEASE may_treat dextromethorphan hydrobromide MEDRT D003371 Cough DISEASE may_prevent dextromethorphan hydrobromide MEDRT D003371 Cough DISEASE may_prevent dextromethorphan MEDRT D003371 Cough DISEASE may_treat dextromethorphan MEDRT D004342 Drug Hypersensitivity DISEASE ci_with quinidine MEDRT D004342 Drug Hypersensitivity DISEASE ci_with dextromethorphan hydrobromide MEDRT D004342 Drug Hypersensitivity DISEASE ci_with quinidine sulfate MEDRT D004342 Drug Hypersensitivity DISEASE ci_with dextromethorphan MEDRT D006327 Heart Block DISEASE ci_with quinidine MEDRT D006327 Heart Block DISEASE ci_with quinidine sulfate MEDRT D016778 Malaria, Falciparum DISEASE may_prevent quinidine MEDRT D016778 Malaria, Falciparum DISEASE may_prevent quinidine sulfate MEDRT D009157 Myasthenia Gravis DISEASE ci_with quinidine MEDRT D009157 Myasthenia Gravis DISEASE ci_with quinidine sulfate MEDRT D011696 Purpura, Thrombocytopenic DISEASE ci_with quinidine sulfate MEDRT D011696 Purpura, Thrombocytopenic DISEASE ci_with quinidine MEDRT D013617 Tachycardia, Supraventricular DISEASE may_prevent quinidine sulfate MEDRT D013617 Tachycardia, Supraventricular DISEASE may_prevent quinidine MEDRT D017180 Tachycardia, Ventricular DISEASE may_prevent quinidine MEDRT D017180 Tachycardia, Ventricular DISEASE may_prevent quinidine sulfate MEDRT D018754 Ventricular Dysfunction DISEASE ci_with quinidine MEDRT D018754 Ventricular Dysfunction DISEASE ci_with quinidine sulfate MEDRT N0000000140 Calcium Channel Interactions MOA has_moa quinidine MEDRT N0000000140 Calcium Channel Interactions MOA has_moa quinidine sulfate MEDRT N0000000184 Monoamine Oxidase Inhibitors MOA ci_moa dextromethorphan hydrobromide MEDRT N0000000184 Monoamine Oxidase Inhibitors MOA ci_moa dextromethorphan MEDRT N0000000211 Potassium Channel Interactions MOA has_moa quinidine MEDRT N0000000211 Potassium Channel Interactions MOA has_moa quinidine sulfate MEDRT N0000000109 Serotonin Uptake Inhibitors MOA has_moa dextromethorphan hydrobromide MEDRT N0000000109 Serotonin Uptake Inhibitors MOA has_moa dextromethorphan MEDRT N0000182147 Sigma-1 Receptor Agonists MOA has_moa dextromethorphan hydrobromide MEDRT N0000182147 Sigma-1 Receptor Agonists MOA has_moa dextromethorphan MEDRT N0000000180 Sodium Channel Interactions MOA has_moa quinidine sulfate MEDRT N0000000180 Sodium Channel Interactions MOA has_moa quinidine MEDRT N0000181819 Uncompetitive NMDA Receptor Antagonists MOA has_moa dextromethorphan hydrobromide MEDRT N0000181819 Uncompetitive NMDA Receptor Antagonists MOA has_moa dextromethorphan MEDRT N0000008330 Cardiac Rhythm Alteration PE has_pe quinidine MEDRT N0000008330 Cardiac Rhythm Alteration PE has_pe quinidine sulfate MEDRT N0000008701 Decreased Medullary Respiratory Drive PE has_pe dextromethorphan hydrobromide MEDRT N0000008701 Decreased Medullary Respiratory Drive PE has_pe dextromethorphan
Properties# Category, Property, Value table Category Property Value ATTRIBUTES AVAILABLE_STRENGTH 20 MG / 10 MG ATTRIBUTES GENERAL_CARDINALITY MULTI ATTRIBUTES HUMAN_DRUG US ATTRIBUTES PRESCRIBABLE Y ATTRIBUTES RXNAV_HUMAN_DRUG US ATTRIBUTES SCHEDULE 0 ATTRIBUTES TTY SBD CODES MMSL_CODE BD26602 CODES NDA NDA021879 CODES RxCUI 1040058 CODES SPL_SET_ID 484e0918-3442-49dc-8ccf-177f1f3ee9f3 CODES SPL_SET_ID c8cce784-8c5f-415b-8068-76e5d481d159 NAMES Prescribable Synonym NUEDEXTA 20 MG / 10 MG Oral Capsule NAMES RXNAV_STR Nuedexta (dextromethorphan hydrobromide 20 MG / quiNIDine sulfate 10 MG) Oral Capsule NAMES RxNorm Name dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG Oral Capsule [Nuedexta] NAMES RxNorm Synonym Nuedexta (dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG) Oral Capsule NAMES Tallman Synonym dextromethorphan hydrobromide 20 MG / quiNIDine sulfate 10 MG Oral Capsule [Nuedexta] NAMES Tallman Synonym Nuedexta (dextromethorphan hydrobromide 20 MG / quiNIDine sulfate 10 MG) Oral Capsule SOURCES Source Gold Standard Alchemy SOURCES Source Metathesaurus FDA Structured Product Labels SOURCES Source Micromedex RED BOOK SOURCES Source Multum MediSource Lexicon