Rugby Chest Congestion Relief Tablet
NDC Package 0536-1309-08

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

Rugby Chest Congestion Relief (guaifenesin/phenylephrine) tablets is ■ adults and children 12 years and over:take 1 caplet every 4 hours as needed■ children 6 to under 12 years:take 1/2 caplet every 4 hours as needed■ children under 6 years: consult a doctorDo not exceed 6 doses in a 24 hour period or as directed by a doctor. This formulation utilizes a tablet delivery system. Marketed by Rugby Laboratories, this product is identified by NDC 0536-1309 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0536-1309-08
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 60 TABLET in 1 BOTTLE, PLASTIC
Product Code
0536-1309
11-Digit Billing Format
00536130908
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: 1304111 - guaiFENesin 400 MG / phenylephrine HCl 10 MG Oral Tablet
  • RxCUI: 1304111 - guaifenesin 400 MG / phenylephrine hydrochloride 10 MG Oral Tablet

Clinical Specifications

Proprietary Name
Rugby Chest Congestion Relief PE
Non-Proprietary Name
Guaifenesin/phenylephrine
Substance Name
Guaifenesin; Phenylephrine Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
■ adults and children 12 years and over:take 1 caplet every 4 hours as needed■ children 6 to under 12 years:take 1/2 caplet every 4 hours as needed■ children under 6 years: consult a doctorDo not exceed 6 doses in a 24 hour period or as directed by a doctor.

Regulatory & Marketing

Labeler Name
Rugby Laboratories
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-09-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0536-1309). Click a package code to view its specific billing and regulatory data.

0536-1309-07
1 BOTTLE, PLASTIC in 1 CARTON / 30 TABLET in 1 BOTTLE, PLASTIC

* 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 0536-1309-08 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 60 tablet in 1 bottle, plastic of Rugby Chest Congestion Relief PE, a human over the counter drug labeled by Rugby Laboratories. This tablet is formulated for oral use and contains guaifenesin; phenylephrine hydrochloride 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 September 09, 2020. 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: 00536130908. 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)
0536-1309-08
11-Digit CMS (5-4-2)
00536-1309-08

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