nuedexta

Generic: dextromethorphan hydrobromide and quinidine sulfate

Labeler: avanir pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nuedexta
Generic Name dextromethorphan hydrobromide and quinidine sulfate
Labeler avanir pharmaceuticals, inc.
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 20 mg/1, quinidine sulfate 10 mg/1

Manufacturer
Avanir Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 64597-301
Product ID 64597-301_545d121c-01b2-4375-9067-52fc8ad23d74
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021879
Listing Expiration 2026-12-31
Marketing Start 2010-12-01

Pharmacologic Class

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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64597301
Hyphenated Format 64597-301

Supplemental Identifiers

RxCUI
1040054 1040058
UNII
9D2RTI9KYH J13S2394HE

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nuedexta (source: ndc)
Generic Name dextromethorphan hydrobromide and quinidine sulfate (source: ndc)
Application Number NDA021879 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (64597-301-13) / 13 CAPSULE, GELATIN COATED in 1 BOTTLE
  • 60 CAPSULE, GELATIN COATED in 1 BOTTLE (64597-301-60)
source: ndc

Packages (2)

64597-301-13 1 BOTTLE in 1 CARTON (64597-301-13) / 13 CAPSULE, GELATIN COATED in 1 BOTTLE 64597-301-60 60 CAPSULE, GELATIN COATED in 1 BOTTLE (64597-301-60)

Ingredients (2)

dextromethorphan hydrobromide (20 mg/1) quinidine sulfate (10 mg/1)

Linked Drug Pages (1)

NUEDEXTA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "545d121c-01b2-4375-9067-52fc8ad23d74", "openfda": {"unii": ["9D2RTI9KYH", "J13S2394HE"], "rxcui": ["1040054", "1040058"], "spl_set_id": ["484e0918-3442-49dc-8ccf-177f1f3ee9f3"], "manufacturer_name": ["Avanir Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (64597-301-13)  / 13 CAPSULE, GELATIN COATED in 1 BOTTLE", "package_ndc": "64597-301-13", "marketing_end_date": "20260813", "marketing_start_date": "20101201"}, {"sample": false, "description": "60 CAPSULE, GELATIN COATED in 1 BOTTLE (64597-301-60)", "package_ndc": "64597-301-60", "marketing_end_date": "20260813", "marketing_start_date": "20101201"}], "brand_name": "NUEDEXTA", "product_id": "64597-301_545d121c-01b2-4375-9067-52fc8ad23d74", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["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]"], "product_ndc": "64597-301", "generic_name": "dextromethorphan hydrobromide and quinidine sulfate", "labeler_name": "Avanir Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NUEDEXTA", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/1"}, {"name": "QUINIDINE SULFATE", "strength": "10 mg/1"}], "application_number": "NDA021879", "marketing_category": "NDA", "marketing_start_date": "20101201", "listing_expiration_date": "20261231"}