Guaifenesin And Dextromethorphan Hydrobromide
NDC Package 51660-054-41

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 tablettake with a full glass of waterthis product can be administered without regard for timing of mealsadults and children 12 years and older: 1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hourschildren under 12 years of age: do not use. Marketed by Ohm Laboratories Inc, this product is identified by NDC 51660-054 and is authorized under FDA application NDA021620.

Identification & Billing

NDC Package Code
51660-054-41
Package Description
1 BLISTER PACK in 1 CARTON / 40 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
51660-054
11-Digit Billing Format
51660005441
RxNorm Crosswalk
  • RxCUI: 1298324 - guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1298324 - 12 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral Tablet
  • RxCUI: 1298324 - dextromethorphan hydrobromide 30 MG / guaifenesin 600 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 tablettake with a full glass of waterthis product can be administered without regard for timing of mealsadults and children 12 years and older: 1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hourschildren under 12 years of age: do not use

Regulatory & Marketing

Labeler Name
Ohm Laboratories Inc
FDA Application #
NDA021620
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-01-2019
Listing Expiration
12-31-2021
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 51660-054-41 identifies a specific commercial package of 1 blister pack in 1 carton / 40 tablet, extended release in 1 blister pack of Guaifenesin And Dextromethorphan Hydrobromide, labeled by Ohm Laboratories Inc. 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 Ohm Laboratories Inc on October 01, 2019. The current certification is valid through December 31, 2021.

How is this Ohm Laboratories Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51660005441. 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)
51660-054-41
11-Digit CMS (5-4-2)
51660-0054-41

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