Dextromethorphan Polistirex Extended Release
NDC Package 50436-0433-1

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.

Dextromethorphan Polistirex Extended Release is •shake bottle well before use•measure only with dosing cup provided•do not use dosing cup with other products•dose as follows or as directed by doctor•mL = milliliteradults and children 12 years of age and over10 mL every 12 hours, not to exceed 20 mL in 24 hourschildren 6 to under 12 years of age5 mL every 12 hours, not to exceed 10 mL in 24 hourschildren 4 to under 6 years of age2.5 mL every 12 hours, not to exceed 5 mL in 24 hourschildren under 4 years of agedo not use. Marketed by Unit Dose Services, this product is identified by NDC 50436-0433 and is authorized under FDA application ANDA091135.

Identification & Billing

NDC Package Code
50436-0433-1
Package Description
1 BOTTLE in 1 CARTON / 89 mL in 1 BOTTLE
Product Code
50436-0433
11-Digit Billing Format
50436043301
RxNorm Crosswalk
  • RxCUI: 1373045 - dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral Suspension
  • RxCUI: 1373045 - 12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension
  • RxCUI: 1373045 - dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension
  • RxCUI: 1373045 - dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension

Clinical Specifications

Proprietary Name
Dextromethorphan Polistirex Extended Release
Dosage Form
-
Usage Information
•shake bottle well before use•measure only with dosing cup provided•do not use dosing cup with other products•dose as follows or as directed by doctor•mL = milliliteradults and children 12 years of age and over10 mL every 12 hours, not to exceed 20 mL in 24 hourschildren 6 to under 12 years of age5 mL every 12 hours, not to exceed 10 mL in 24 hourschildren 4 to under 6 years of age2.5 mL every 12 hours, not to exceed 5 mL in 24 hourschildren under 4 years of agedo not use

Regulatory & Marketing

Labeler Name
Unit Dose Services
FDA Application #
ANDA091135
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-10-2012
Listing Expiration
12-31-2020
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 50436-0433-1 identifies a specific commercial package of 1 bottle in 1 carton / 89 ml in 1 bottle of Dextromethorphan Polistirex Extended Release, labeled by Unit Dose Services. 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 Unit Dose Services on September 10, 2012. The current certification is valid through December 31, 2020.

How is this Unit Dose Services product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50436043301. 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 (5-4-1)
50436-0433-1
11-Digit CMS (5-4-2)
50436-0433-01

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