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  4. NDC Product Code: 64597-301 Nuedexta

NDC 64597-301 Nuedexta

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 64597-301?
  5. Nuedexta Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Get all the details for National Drug Code (NDC) 64597-301 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
64597-301
Proprietary Name:
Nuedexta
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
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.
Start Marketing Date: [9]
12-01-2010
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
I
Code Navigator:

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 which is product labeled by Avanir Pharmaceuticals, Inc.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 64597-301-13 1 bottle in 1 carton / 13 capsule, gelatin coated in 1 bottle, 64597-301-60 60 capsule, gelatin coated in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Nuedexta?

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.

Which are Nuedexta UNII Codes?

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

Which are Nuedexta Inactive Ingredients 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 Nuedexta?

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

* Please review the disclaimer below.

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 disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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".