Dextromethorphan / Quinidine Oral Capsule

Brand(s)
Nuedexta
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Avanir Pharmaceuticals, Inc. (2015-01-30)
Oldest Current Product
2010-12-01
License(s)
NDA
RxNORM
ORAL CAPSULE\DEXTROMETHORPHAN:QUINIDINE
FDAOB
ORAL\CAPSULE\DEXTROMETHORPHAN HYDROBROMIDE: QUINIDINE SULFATE
SPL Active
ORAL\CAPSULE, GELATIN COATED\DEXTROMETHORPHAN HYDROBROMIDE: QUINIDINE SULFATE
SPL Moiety
ORAL\CAPSULE, GELATIN COATED\DEXTROMETHORPHAN: QUINIDINE

product(s) by strength(s)

dextromethorphan hydrobromide 20 mg / quinidine sulfate 10 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1645970301NuedextaNDAAvanir Pharmaceuticals, Inc.2010-12-01DEXTROMETHORPHAN HYDROBROMIDE, QUINIDINE SULFATEORALCAPSULE, GELATIN COATEDNDA021879484e0918-3442-49dc-8ccf-177f1f3ee9f3

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA021879NUEDEXTAAVANIR PHARMACEUTICALS INC2010-10-29pRE38115, SUBSTANCE
p8227484, TREATMENT OF PSEUDOBULBAR AFFECT
p7659282, TREATMENT OF PSEUDOBULBAR AFFECT
NDA021879_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021879_001RXDEXTROMETHORPHAN HYDROBROMIDE (20MG), QUINIDINE SULFATE (10MG)ORALCAPSULETrue2010-10-29NUEDEXTA

patent(s)

#idexpiration dateapplication(s)
1p7659282 (view patent)2026-08-13NDA021879
2p8227484 (view patent)2023-07-17NDA021879
3pRE38115 (view patent)2016-01-26NDA021879

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1484e0918-3442-49dc-8ccf-177f1f3ee9f3 (view SPL)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: 2010prescriptionHuman PrescriptionAvanir Pharmaceuticals, Inc.MANUFACTURE2015-01-3012645970301

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII