nuedexta

Generic: dextromethorphan hydrobromide and quinidine sulfate

Labeler: otsuka america pharmaceutical, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nuedexta
Generic Name dextromethorphan hydrobromide and quinidine sulfate
Labeler otsuka america pharmaceutical, inc
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Otsuka America Pharmaceutical, Inc

Identifiers & Regulatory

Product NDC 59148-053
Product ID 59148-053_b73848d5-ceb2-482a-99bd-a2b6b895abae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021879
Listing Expiration 2027-12-31
Marketing Start 2023-01-03

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 59148053
Hyphenated Format 59148-053

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
  • 60 CAPSULE, GELATIN COATED in 1 BOTTLE (59148-053-16)
  • 4 CARTON in 1 BOX (59148-053-98) / 1 BOTTLE in 1 CARTON (59148-053-07) / 13 CAPSULE, GELATIN COATED in 1 BOTTLE
source: ndc

Packages (2)

59148-053-16 60 CAPSULE, GELATIN COATED in 1 BOTTLE (59148-053-16) 59148-053-98 4 CARTON in 1 BOX (59148-053-98) / 1 BOTTLE in 1 CARTON (59148-053-07) / 13 CAPSULE, GELATIN COATED in 1 BOTTLE

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": "b73848d5-ceb2-482a-99bd-a2b6b895abae", "openfda": {"unii": ["9D2RTI9KYH", "J13S2394HE"], "rxcui": ["1040054", "1040058"], "spl_set_id": ["c8cce784-8c5f-415b-8068-76e5d481d159"], "manufacturer_name": ["Otsuka America Pharmaceutical, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, GELATIN COATED in 1 BOTTLE (59148-053-16)", "package_ndc": "59148-053-16", "marketing_start_date": "20230103"}, {"sample": false, "description": "4 CARTON in 1 BOX (59148-053-98)  / 1 BOTTLE in 1 CARTON (59148-053-07)  / 13 CAPSULE, GELATIN COATED in 1 BOTTLE", "package_ndc": "59148-053-98", "marketing_start_date": "20230103"}], "brand_name": "Nuedexta", "product_id": "59148-053_b73848d5-ceb2-482a-99bd-a2b6b895abae", "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": "59148-053", "generic_name": "dextromethorphan hydrobromide and quinidine sulfate", "labeler_name": "Otsuka America Pharmaceutical, 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": "20230103", "listing_expiration_date": "20271231"}