Guaifenesin And Dextromethorphan Hbr
NDC Package 84447-102-01

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

Package Information

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

Guaifenesin And Dextromethorphan Hbr is uses:■ helps loosen phlegm(mucus) and thin bronchial secretions to make coughs more productive■ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold. Marketed by Belleview Biosciences, this product is identified by NDC 84447-102 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
84447-102-01
Package Description
200000 mL in 1 DRUM
Product Code
84447-102
11-Digit Billing Format
84447010201
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
Guaifenesin And Dextromethorphan Hbr
Dosage Form
-
Usage Information
Uses:■ helps loosen phlegm(mucus) and thin bronchial secretions to make coughs more productive■ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Regulatory & Marketing

Labeler Name
Belleview Biosciences
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-20-2024
Listing Expiration
12-31-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 84447-102-01 identifies a specific commercial package of 200000 ml in 1 drum of Guaifenesin And Dextromethorphan Hbr, labeled by Belleview Biosciences. 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 Belleview Biosciences on July 20, 2024. The current certification is valid through December 31, 2025.

How is this Belleview Biosciences product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84447010201. 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)
84447-102-01
11-Digit CMS (5-4-2)
84447-0102-01

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