Dextromethorphan Hbr And Guaifenesin
NDC Package 50383-062-07

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

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

Dextromethorphan Hbr And Guaifenesin is •take every 4 hours•do not exceed 6 doses in 24 hoursAgeDoseAdults & children 12 years & over10 mL (2 teaspoonfuls)Children 6 years to under 12 years5 mL (1 teaspoonful)Children 2 years to under 6 years2.5 mL (1/2 teaspoonful)Children under 2 yearsAsk a doctorHow Supplied: Dextromethorphan HBr and Guaifenesin Oral Solution is a clear viscous liquid with a slight cherry odor supplied in the following oral dosage forms: 5 mL unit dose, 10 mL unit dose in trays of 10 and 4 fl. Marketed by Akorn, this product is identified by NDC 50383-062 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
50383-062-07
Package Description
10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE
Product Code
50383-062
11-Digit Billing Format
50383006207
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 996520 - dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution
  • RxCUI: 996520 - dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution
  • RxCUI: 996520 - dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution
  • RxCUI: 996520 - dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution
  • RxCUI: 996520 - dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution

Clinical Specifications

Proprietary Name
Dextromethorphan Hbr And Guaifenesin
Dosage Form
-
Usage Information
•take every 4 hours•do not exceed 6 doses in 24 hoursAgeDoseAdults & children 12 years & over10 mL (2 teaspoonfuls)Children 6 years to under 12 years5 mL (1 teaspoonful)Children 2 years to under 6 years2.5 mL (1/2 teaspoonful)Children under 2 yearsAsk a doctorHow Supplied: Dextromethorphan HBr and Guaifenesin Oral Solution is a clear viscous liquid with a slight cherry odor supplied in the following oral dosage forms: 5 mL unit dose, 10 mL unit dose in trays of 10 and 4 fl. oz. (118 mL) bottlePhenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)Storage: Keep tightly closed. Store at controlled room temperature 20-25° C (68-77°F). [See USP] Protect from light.

Regulatory & Marketing

Labeler Name
Akorn
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
03-07-2012
Listing Expiration
12-31-2023
Exclude Flag
I
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 (50383-062). Click a package code to view its specific billing and regulatory data.

50383-062-06
4 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY (50383-062-05) / 5 mL in 1 CUP, UNIT-DOSE
50383-062-11
4 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY (50383-062-10) / 10 mL in 1 CUP, UNIT-DOSE
50383-062-12
10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE

* 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 50383-062-07 identifies a specific commercial package of 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 ml in 1 cup, unit-dose of Dextromethorphan Hbr And Guaifenesin, labeled by Akorn. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Akorn on March 07, 2012. The current certification is valid through December 31, 2023.

How is this Akorn product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50383006207. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
50383-062-07
11-Digit CMS (5-4-2)
50383-0062-07

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