FDA.reportPublic FDA data

NUEDEXTA

Product NDC
64597-301
11-digit product format
645970301
Labeler code
64597
Product ID
64597-301_545d121c-01b2-4375-9067-52fc8ad23d74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dextromethorphan hydrobromide and quinidine sulfate
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Avanir Pharmaceuticals, Inc.
Application
NDA021879
Marketing category
NDA
Marketing start
2010-12-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE
Active strength
20; 10 mg/1; mg/1
Pharmacologic classes
Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NUEDEXTA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/1
QUINIDINE SULFATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, J13S2394HE
Rxcui1040054, 1040058

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
5c89f85a-bde6-5cf8-a351-de14631f6a68Product name220220315
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
3cea42cf-df28-7a4d-1e04-432ad7cc2928Product name120140508
607c7c15-7bf2-457f-7c66-b7729171afe6Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64597-301-132025-11-10C16284748780-12cef2736-5ba0-d83d-e063-dadaa90ab31fThese 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
64597-301-132025-11-10C16284748780-12cef2736-5ba0-d83d-e063-dadaa90ab31fThese 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
64597-301-602025-11-10C16284748780-12cef2736-5ba0-d83d-e063-dadaa90ab31fThese 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
64597-301-602025-11-10C16284748780-12cef2736-5ba0-d83d-e063-dadaa90ab31fThese 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
64597-301-132025-01-30C16284748780-12cef2736-5ba0-d83d-e063-dadaa90ab31fThese 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
64597-301-132025-01-30C16284748780-12cef2736-5ba0-d83d-e063-dadaa90ab31fThese 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
64597-301-602025-01-30C16284748780-12cef2736-5ba0-d83d-e063-dadaa90ab31fThese 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
64597-301-602025-01-30C16284748780-12cef2736-5ba0-d83d-e063-dadaa90ab31fThese 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64597-301-13NUEDEXTA13 in 1 BOTTLECAPSULE, GELATIN COATED1329
64597-301-13NUEDEXTA1 in 1 CARTONCAPSULE, GELATIN COATED129
64597-301-60NUEDEXTA60 in 1 BOTTLECAPSULE, GELATIN COATED6029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64597-301-60EA - Each64597-301cdcc20c8-db29-43c9-aef2-f105e5b5887812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHNUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE) CAPSULE, GELATIN COATED [AVANIR PHARMACEUTICALS, INC.]12
QUINIDINE SULFATEACTIVE INGREDIENTJ13S2394HENUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE) CAPSULE, GELATIN COATED [AVANIR PHARMACEUTICALS, INC.]12
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSNUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE) CAPSULE, GELATIN COATED [AVANIR PHARMACEUTICALS, INC.]12
QUINIDINEACTIVE MOIETYITX08688JLNUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE) CAPSULE, GELATIN COATED [AVANIR PHARMACEUTICALS, INC.]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE) CAPSULE, GELATIN COATED [AVANIR PHARMACEUTICALS, INC.]12
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE) CAPSULE, GELATIN COATED [AVANIR PHARMACEUTICALS, INC.]12
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE) CAPSULE, GELATIN COATED [AVANIR PHARMACEUTICALS, INC.]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE) CAPSULE, GELATIN COATED [AVANIR PHARMACEUTICALS, INC.]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE) CAPSULE, GELATIN COATED [AVANIR PHARMACEUTICALS, INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64597-301NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE) CAPSULE, GELATIN COATED [AVANIR PHARMACEUTICALS, INC.]28Current NDC, Legacy NDC, 3 package rows20231208_484e0918-3442-49dc-8ccf-177f1f3ee9f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1040054dextromethorphan HBr 20 MG / quiNIDine sulfate 10 MG Oral CapsulePSN484e0918-3442-49dc-8ccf-177f1f3ee9f329
1040058NUEDEXTA 20 MG / 10 MG Oral CapsulePSN484e0918-3442-49dc-8ccf-177f1f3ee9f329
1040058dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG Oral Capsule [Nuedexta]SBD484e0918-3442-49dc-8ccf-177f1f3ee9f329
1040054dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG Oral CapsuleSCD484e0918-3442-49dc-8ccf-177f1f3ee9f329
1040058Nuedexta (dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG) Oral CapsuleSY484e0918-3442-49dc-8ccf-177f1f3ee9f329

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64597-301-13645970301131 BOTTLE in 1 CARTON (64597-301-13) / 13 CAPSULE, GELATIN COATED in 1 BOTTLE1 bottle2010-12-012026-08-13NoNoCurrent
64597-301-606459703016060 CAPSULE, GELATIN COATED in 1 BOTTLE (64597-301-60) 2010-12-012026-08-13NoNoCurrent