Hydrocodone Polistirex And Chlorpheniramine Polistirex Suspension, Extended Release
NDC Package 27808-086-01

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

Hydrocodone Polistirex And Chlorpheniramine Polistirex suspension is 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. This formulation utilizes a suspension, extended release delivery system. Marketed by Cranbury Pharmaceuticals, Llc, this product is identified by NDC 27808-086 and is authorized under FDA application ANDA091632.

Identification & Billing

NDC Package Code
27808-086-01
Package Description
1 BOTTLE, UNIT-DOSE in 1 CARTON / 115 mL in 1 BOTTLE, UNIT-DOSE
Product Code
27808-086
11-Digit Billing Format
27808008601
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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
Non-Proprietary Name
Hydrocodone Polistirex And Chlorpheniramine Polistirex
Substance Name
Chlorpheniramine Maleate; Hydrocodone Bitartrate
Dosage Form
Suspension, Extended Release - A liquid preparation consisting of solid particles dispersed throughout a liquid phase in which the particles are not soluble; the suspension has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution or a prompt drug-releasing, conventional solid dosage form).
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Cranbury Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA091632
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-06-2015
Listing Expiration
12-31-2027
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 (27808-086). Click a package code to view its specific billing and regulatory data.

27808-086-02
473 mL in 1 BOTTLE
27808-086-03
1 BOTTLE, UNIT-DOSE in 1 CARTON / 70 mL in 1 BOTTLE, UNIT-DOSE

* 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 27808-086-01 identifies a specific commercial package of 1 bottle, unit-dose in 1 carton / 115 ml in 1 bottle, unit-dose of Hydrocodone Polistirex And Chlorpheniramine Polistirex Extended-release, a human prescription drug labeled by Cranbury Pharmaceuticals, Llc. This suspension, extended release is formulated for oral use and contains chlorpheniramine maleate; hydrocodone bitartrate 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 Cranbury Pharmaceuticals, Llc on March 06, 2015. The current certification is valid through December 31, 2027.

How is this Cranbury Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 27808008601. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
27808-086-01
11-Digit CMS (5-4-2)
27808-0086-01

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