Guaifenesin And Dextromethorphan Hydrobromide
NDC Package 49035-077-28

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 Hydrobromide is •do not crush, chew, or break tablet•take with a full glass of water•this product can be administered without regard for timing of meals•adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours•children under 12 years of age: do not use. Marketed by Walmart Stores, Inc., this product is identified by NDC 49035-077 and is authorized under FDA application NDA021620.

Identification & Billing

NDC Package Code
49035-077-28
Package Description
2 BLISTER PACK in 1 CARTON / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
49035-077
11-Digit Billing Format
49035007728
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
2 EA
RxNorm Crosswalk
  • RxCUI: 1099074 - guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1099074 - 12 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral Tablet
  • RxCUI: 1099074 - dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Guaifenesin And Dextromethorphan Hydrobromide
Dosage Form
-
Usage Information
•do not crush, chew, or break tablet•take with a full glass of water•this product can be administered without regard for timing of meals•adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours•children under 12 years of age: do not use

Regulatory & Marketing

Labeler Name
Walmart Stores, Inc.
FDA Application #
NDA021620
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-15-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 49035-077-28 identifies a specific commercial package of 2 blister pack in 1 carton / 14 tablet, extended release in 1 blister pack of Guaifenesin And Dextromethorphan Hydrobromide, labeled by Walmart Stores, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 2 billable units per package. 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 Walmart Stores, Inc. on October 15, 2017. The current certification is valid through December 31, 2023.

How is this Walmart Stores, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49035007728. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2 total billable units per package. 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)
49035-077-28
11-Digit CMS (5-4-2)
49035-0077-28

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