Hydrocodone Polistirex And Chlorpheniramine Polistirex
NDC Package 17856-0087-2

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.

Hydrocodone Polistirex And Chlorpheniramine Polistirex is extended-Release Suspension is indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.Important Limitations of Use:• Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)].• Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4)].• Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve Hydrocodone Polistirex and Chlorpheniramine Polistirex for use in adult patients for whomthe benefits of cough suppression are expected to outweigh the risks, and in whom an adequateassessment of the etiology of the cough has been made. Marketed by Atlantic Biologicals Corp., this product is identified by NDC 17856-0087 and is authorized under FDA application ANDA091632.

Identification & Billing

NDC Package Code
17856-0087-2
Package Description
1 BOX, UNIT-DOSE in 1 CUP, UNIT-DOSE / 5 BOX, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0087-3) / 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0087-1) / 5 mL in 1 CUP, UNIT-DOSE
Product Code
17856-0087
11-Digit Billing Format
17856008702
RxNorm Crosswalk
  • RxCUI: 1087459 - HYDROcodone polistirex 10 MG / chlorpheniramine polistirex 8 MG in 5 mL 12HR Extended Release Oral Suspension
  • RxCUI: 1087459 - 12 HR chlorpheniramine polistirex 1.6 MG/ML / hydrocodone polistirex 2 MG/ML Extended Release Suspension
  • RxCUI: 1087459 - hydrocodone polistirex 10 MG / chlorpheniramine polistirex 8 MG per 5 ML 12HR Extended Release Oral Suspension

Clinical Specifications

Proprietary Name
Hydrocodone Polistirex And Chlorpheniramine Polistirex Extended-release
Dosage Form
-
Usage Information
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension is indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.Important Limitations of Use:• Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)].• Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4)].• Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve Hydrocodone Polistirex and Chlorpheniramine Polistirex for use in adult patients for whomthe benefits of cough suppression are expected to outweigh the risks, and in whom an adequateassessment of the etiology of the cough has been made.

Regulatory & Marketing

Labeler Name
Atlantic Biologicals Corp.
FDA Application #
ANDA091632
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-06-2015
Listing Expiration
12-31-2024
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 17856-0087-2 identifies a specific commercial package of 1 box, unit-dose in 1 cup, unit-dose / 5 box, unit-dose in 1 box, unit-dose (17856-0087-3) / 72 cup, unit-dose in 1 box, unit-dose (17856-0087-1) / 5 ml in 1 cup, unit-dose of Hydrocodone Polistirex And Chlorpheniramine Polistirex Extended-release, labeled by Atlantic Biologicals Corp.. 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 Atlantic Biologicals Corp. on March 06, 2015. The current certification is valid through December 31, 2024.

How is this Atlantic Biologicals Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856008702. 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)
17856-0087-2
11-Digit CMS (5-4-2)
17856-0087-02

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