Codeine And Chlorpheniramine Maleate Er
NDC Package 0722-7184-01

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.

Codeine And Chlorpheniramine Maleate Er is cODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE 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.Important Limitations of UseNot indicated for pediatric patients under 18 years of age [see Use in Special Population (8.4)]. Marketed by Nexgen Pharma, Inc., this product is identified by NDC 0722-7184 and is authorized under FDA application NDA206323.

Identification & Billing

NDC Package Code
0722-7184-01
Package Description
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
0722-7184
11-Digit Billing Format
00722718401
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

Clinical Specifications

Proprietary Name
Codeine And Chlorpheniramine Maleate Er
Dosage Form
-
Usage Information
CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE 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.Important Limitations of UseNot indicated for pediatric patients under 18 years of age [see Use in Special Population (8.4)]

Regulatory & Marketing

Labeler Name
Nexgen Pharma, Inc.
FDA Application #
NDA206323
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-01-2015
Listing Expiration
12-31-2018
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 0722-7184-01 identifies a specific commercial package of 100 tablet, extended release in 1 bottle of Codeine And Chlorpheniramine Maleate Er, labeled by Nexgen Pharma, 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 Nexgen Pharma, Inc. on September 01, 2015. The current certification is valid through December 31, 2018.

How is this Nexgen Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00722718401. 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)
0722-7184-01
11-Digit CMS (5-4-2)
00722-7184-01

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