Tuxarin Tablet, Extended Release
NDC Package 71269-040-30

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

Tuxarin (codeine phosphate and chlorpheniramine maleate) tablets is tUXARIN ER is indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older. This formulation utilizes a tablet, extended release delivery system. Marketed by Mainpointe Pharmaceuticals, this product is identified by NDC 71269-040 and is authorized under FDA application NDA206323.

Identification & Billing

NDC Package Code
71269-040-30
Package Description
30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
71269-040
11-Digit Billing Format
71269004030
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 1664543 - codeine phosphate 54.3 MG / chlorpheniramine maleate 8 MG 12HR Oral Extended Release Tablet
  • RxCUI: 1664543 - 12 HR chlorpheniramine maleate 8 MG / codeine phosphate 54.3 MG Extended Release Oral Tablet
  • RxCUI: 1664543 - chlorpheniramine maleate 8 MG / codeine phosphate 54.3 MG 12HR Oral Extended Release Tablet
  • RxCUI: 2099286 - Tuxarin ER 54.3 MG / 8 MG 12HR Extended Release Oral Tablet
  • RxCUI: 2099286 - 12 HR chlorpheniramine maleate 8 MG / codeine phosphate 54.3 MG Extended Release Oral Tablet [Tuxarin]

Clinical Specifications

Proprietary Name
Tuxarin
Non-Proprietary Name
Codeine Phosphate And Chlorpheniramine Maleate
Substance Name
Chlorpheniramine Maleate; Codeine Phosphate
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
TUXARIN ER is indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older.
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Mainpointe Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
NDA206323
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-15-2018
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 (71269-040). Click a package code to view its specific billing and regulatory data.

71269-040-10
100 TABLET, EXTENDED RELEASE 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 71269-040-30 identifies a specific commercial package of 30 tablet, extended release in 1 bottle, plastic of Tuxarin, a human prescription drug labeled by Mainpointe Pharmaceuticals. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This tablet, extended release is formulated for oral use and contains chlorpheniramine maleate; codeine phosphate 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 Mainpointe Pharmaceuticals on October 15, 2018. The current certification is valid through December 31, 2026.

How is this Mainpointe Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71269004030. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
71269-040-30
11-Digit CMS (5-4-2)
71269-0040-30

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