FDA.reportPublic FDA data

Nuedexta

Product NDC
59148-053
11-digit product format
591480053
Labeler code
59148
Product ID
59148-053_b73848d5-ceb2-482a-99bd-a2b6b895abae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dextromethorphan hydrobromide and quinidine sulfate
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Otsuka America Pharmaceutical, Inc
Application
NDA021879
Marketing category
NDA
Marketing start
2023-01-03
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nuedexta
Listing expiration
2027-12-31

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
5c89f85a-bde6-5cf8-a351-de14631f6a68Product name220220315
3cea42cf-df28-7a4d-1e04-432ad7cc2928Product name120140508
607c7c15-7bf2-457f-7c66-b7729171afe6Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59148-053-07Nuedexta13 in 1 BOTTLECAPSULE, GELATIN COATED134
59148-053-07Nuedexta1 in 1 CARTONCAPSULE, GELATIN COATED14
59148-053-16Nuedexta60 in 1 BOTTLECAPSULE, GELATIN COATED604
59148-053-98Nuedexta4 in 1 BOXCAPSULE, GELATIN COATED44

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59148-053-16EA - Each59148-053ce7e90a9-423b-45f2-a1de-22c3f630b11812024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59148-053NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE) CAPSULE, GELATIN COATED [OTSUKA AMERICA PHARMACEUTICAL, INC]3Current NDC, Legacy NDC, 4 package rows20241204_c8cce784-8c5f-415b-8068-76e5d481d159.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1040054dextromethorphan HBr 20 MG / quiNIDine sulfate 10 MG Oral CapsulePSNc8cce784-8c5f-415b-8068-76e5d481d1594
1040058NUEDEXTA 20 MG / 10 MG Oral CapsulePSNc8cce784-8c5f-415b-8068-76e5d481d1594
1040058dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG Oral Capsule [Nuedexta]SBDc8cce784-8c5f-415b-8068-76e5d481d1594
1040054dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG Oral CapsuleSCDc8cce784-8c5f-415b-8068-76e5d481d1594
1040058Nuedexta (dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG) Oral CapsuleSYc8cce784-8c5f-415b-8068-76e5d481d1594

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59148-053-075914800530713 in 1 BOTTLEHistorical
59148-053-165914800531660 CAPSULE, GELATIN COATED in 1 BOTTLE (59148-053-16) 2023-01-030000-00-00NoNoCurrent
59148-053-98591480053984 CARTON in 1 BOX (59148-053-98) / 1 BOTTLE in 1 CARTON (59148-053-07) / 13 CAPSULE, GELATIN COATED in 1 BOTTLE4 carton2023-01-030000-00-00NoNoCurrent