Nuedexta Capsule, Gelatin Coated
NDC Package 64597-301-13

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Nuedexta (dextromethorphan hydrobromide and quinidine sulfate) capsules is a medication used to treat a certain mental/mood disorder (pseudobulbar affect). This formulation utilizes a capsule, gelatin coated delivery system. Marketed by Avanir Pharmaceuticals, Inc., this product is identified by NDC 64597-301 and is authorized under FDA application NDA021879.

Identification & Billing

NDC Package Code
64597-301-13
Package Description
1 BOTTLE in 1 CARTON / 13 CAPSULE, GELATIN COATED in 1 BOTTLE
Product Code
64597-301
11-Digit Billing Format
64597030113
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Nuedexta
Non-Proprietary Name
Dextromethorphan Hydrobromide And Quinidine Sulfate
Substance Name
Dextromethorphan Hydrobromide; Quinidine Sulfate
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Avanir Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021879
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-01-2010
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (64597-301). Click a package code to view its specific billing and regulatory data.

64597-301-60
60 CAPSULE, GELATIN COATED in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 64597-301-13 identifies a specific commercial package of 1 bottle in 1 carton / 13 capsule, gelatin coated in 1 bottle of Nuedexta, a human prescription drug labeled by Avanir Pharmaceuticals, Inc.. This capsule, gelatin coated is formulated for oral use and contains dextromethorphan hydrobromide; quinidine sulfate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Avanir Pharmaceuticals, Inc. on December 01, 2010. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Avanir Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64597030113. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
64597-301-13
11-Digit CMS (5-4-2)
64597-0301-13

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.