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  5. NDC Package Code: 63629-2304-1 Hydrocodone Polistirex And Chlorpheniramine Polistirex Extended-release

NDC Package 63629-2304-1 Hydrocodone Polistirex And Chlorpheniramine Polistirex Extended-release

Suspension, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
63629-2304-1
Package Description:
473 mL in 1 BOTTLE, UNIT-DOSE
Product Code:
63629-2304
Proprietary Name:
Hydrocodone Polistirex And Chlorpheniramine Polistirex Extended-release
Non-Proprietary Name:
Hydrocodone Polistirex And Chlorpheniramine Polistirex
Substance Name:
Chlorpheniramine Maleate; Hydrocodone Bitartrate
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.
11-Digit NDC Billing Format:
63629230401
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
473 ML
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bryant Ranch Prepack
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • CHLORPHENIRAMINE MALEATE 8 mg/5mL
  • HYDROCODONE BITARTRATE 10 mg/5mL
    • Pharmacologic Class(es):
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Opioid Agonist - [EPC] (Established Pharmacologic Class)
  • Opioid Agonists - [MoA] (Mechanism of Action)
    • DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA091632
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-06-2015
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 63629-2304-1?

    The NDC Packaged Code 63629-2304-1 is assigned to a package of 473 ml in 1 bottle, unit-dose of Hydrocodone Polistirex And Chlorpheniramine Polistirex Extended-release, a human prescription drug labeled by Bryant Ranch Prepack. The product's dosage form is suspension, extended release and is administered via oral form.This product is billed per "ML" milliliter and contains an estimated amount of 473 billable units per package.

    Is NDC 63629-2304 included in the NDC Directory?

    Yes, Hydrocodone Polistirex And Chlorpheniramine Polistirex Extended-release with product code 63629-2304 is active and included in the NDC Directory. The product was first marketed by Bryant Ranch Prepack on March 06, 2015 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 63629-2304-1?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 473.

    What is the 11-digit format for NDC 63629-2304-1?

    The 11-digit format is 63629230401. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-163629-2304-15-4-263629-2304-01