Rugby Mucus Relief Dm Er Tablet, Extended Release
NDC Package 0536-1446-34

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

Package Information

Rugby Mucus Relief Dm Er (dextromethorphan hydrobromide, guaifenesin) tablets 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 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours •children under 12 years of age: do not use. This formulation utilizes a tablet, extended release delivery system. Marketed by Rugby Laboratories, this product is identified by NDC 0536-1446 and is authorized under FDA application ANDA207602.

Identification & Billing

NDC Package Code
0536-1446-34
Package Description
1 BOTTLE in 1 CARTON / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
0536-1446
11-Digit Billing Format
00536144634
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
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
Rugby Mucus Relief Dm Er
Non-Proprietary Name
Dextromethorphan Hydrobromide, Guaifenesin
Substance Name
Dextromethorphan Hydrobromide; Guaifenesin
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours •children under 12 years of age: do not use

Regulatory & Marketing

Labeler Name
Rugby Laboratories
Product Type
Human Otc Drug
FDA Application #
ANDA207602
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-02-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0536-1446-34 identifies a specific commercial package of 1 bottle in 1 carton / 20 tablet, extended release in 1 bottle of Rugby Mucus Relief Dm Er, a human over the counter drug labeled by Rugby Laboratories. This tablet, extended release is formulated for oral use and contains dextromethorphan hydrobromide; guaifenesin 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 Rugby Laboratories on April 02, 2025. The current certification is valid through December 31, 2026.

How is this Rugby Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00536144634. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (4-4-2)
0536-1446-34
11-Digit CMS (5-4-2)
00536-1446-34

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