Nuedexta Capsule, Gelatin Coated
NDC 64597-301

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 64597-301?
  5. Nuedexta Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Nuedexta (dextromethorphan hydrobromide and quinidine sulfate) is a NDA-approved product labeled by Avanir Pharmaceuticals, Inc.. This medication is used to treat a certain mental/mood disorder (pseudobulbar affect). It is supplied as a red capsule, gelatin coated for oral administration. This product entry covers the primary NDC 64597-301 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
64597-301
Proprietary Name:
Nuedexta
Non-Proprietary Name: [1]
Dextromethorphan Hydrobromide And Quinidine Sulfate
Substance Name: [2]
Dextromethorphan Hydrobromide; Quinidine Sulfate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Avanir Pharmaceuticals, Inc.
Labeler Code:
64597
Product Label ID:
484e0918-3442-49dc-8ccf-177f1f3ee9f3
FDA Application Number: [6]
NDA021879
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
12-01-2010
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
RED (C48326 - BRICK-RED)
Shape:
CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
DMQ;20;10
Score:
1

Code Structure Chart

Product Details

What is NDC 64597-301?

The NDC code 64597-301 is assigned by the FDA to the product Nuedexta. It is commonly known by its generic name, dextromethorphan hydrobromide and quinidine sulfate. This pharmaceutical product is labeled by Avanir Pharmaceuticals, Inc. and is currently categorized as listed product. The medication is a capsule, gelatin coated administered via oral route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 64597-301-13, 64597-301-60. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

This medication is used to treat a certain mental/mood disorder (pseudobulbar affect). This disorder may occur due to various conditions that affect the brain (such as stroke, amyotrophic lateral sclerosis-ALS, multiple sclerosis). This medication may help decrease sudden outbursts of uncontrollable/inappropriate laughing and/or crying. This medication is a combination of 2 ingredients: dextromethorphan and quinidine. Dextromethorphan works in the brain, though it is not known exactly how it helps treat pseudobulbar affect. Quinidine is added to this medication to increase the effect of dextromethorphan.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1 - Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.
  • QUINIDINE SULFATE 10 mg/1 - An optical isomer of quinine, extracted from the bark of the CHINCHONA tree and similar plant species. This alkaloid dampens the excitability of cardiac and skeletal muscles by blocking sodium and potassium currents across cellular membranes. It prolongs cellular ACTION POTENTIALS, and decreases automaticity. Quinidine also blocks muscarinic and alpha-adrenergic neurotransmission.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1040054 - dextromethorphan HBr 20 MG / quiNIDine sulfate 10 MG Oral Capsule
  • RxCUI: 1040054 - dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG Oral Capsule
  • RxCUI: 1040058 - NUEDEXTA 20 MG / 10 MG Oral Capsule
  • RxCUI: 1040058 - dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG Oral Capsule [Nuedexta]
  • RxCUI: 1040058 - Nuedexta (dextromethorphan hydrobromide 20 MG / quinidine sulfate 10 MG) Oral Capsule

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Patient Education

Dextromethorphan and Quinidine


The combination of dextromethorphan and quinidine is used to treat pseudobulbar affect (PBA; a condition of sudden, frequent outbursts of crying or laughing that can not be controlled) in people with certain conditions such as amyotrophic lateral sclerosis (ALS, Lou Gehrig's disease; condition in which the nerves that control muscle movement slowly die, causing the muscles to shrink and weaken) or multiple sclerosis (a disease in which the nerves do not function properly and patients may experience weakness, numbness, loss of muscle coordination and problems with vision, speech, and bladder control). Dextromethorphan is in a class of medications called central nervous system agents. The way it works in the brain to treat PBA is not known. Quinidine is in a class of medications called antiarrhythmics. When combined with dextromethorphan, quinidine works by increasing the amount of dextromethorphan in the body.
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* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".