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  5. NDC Package Code: 58716-433-16 Obredon

NDC Package 58716-433-16 Obredon

Hydrocodone Bitartrate And Guaifenesin Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
58716-433-16
Package Description:
473 mL in 1 BOTTLE
Product Code:
58716-433
Proprietary Name:
Obredon
Non-Proprietary Name:
Hydrocodone Bitartrate And Guaifenesin
Substance Name:
Guaifenesin; Hydrocodone Bitartrate
Usage Information:
OBREDON is indicated for the symptomatic relief of cough and to loosen mucus associated with the common cold in patients 18 years of age and older.OBREDON is indicated for the symptomatic relief of cough and to loosen mucus associated with 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) ]. 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 OBREDON for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [ see Warnings and Precautions ( 5.1) ], reserve OBREDON for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.
11-Digit NDC Billing Format:
58716043316
NDC to RxNorm Crosswalk:
  • RxCUI: 1598284 - Obredon 2.5 MG / 200 MG in 5 mL Oral Solution
  • RxCUI: 1598284 - guaifenesin 40 MG/ML / hydrocodone bitartrate 0.5 MG/ML Oral Solution [Obredon]
  • RxCUI: 1598284 - Obredon (guaifenesin 200 MG / hydrocodone bitartrate 2.5 MG) per 5 ML Oral Solution
  • RxCUI: 859383 - HYDROcodone bitartrate 2.5 MG / guaiFENesin 200 MG in 5 mL Oral Solution
  • RxCUI: 859383 - guaifenesin 40 MG/ML / hydrocodone bitartrate 0.5 MG/ML Oral Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sovereign Pharmaceuticals, Llc
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • GUAIFENESIN 200 mg/5mL
  • HYDROCODONE BITARTRATE 2.5 mg/5mL
    • Pharmacologic Class(es):
  • Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
  • Expectorant - [EPC] (Established Pharmacologic Class)
  • Increased Respiratory Secretions - [PE] (Physiologic Effect)
  • Opioid Agonist - [EPC] (Established Pharmacologic Class)
  • Opioid Agonists - [MoA] (Mechanism of Action)
    • DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    FDA Application Number:
    NDA205474
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-30-2014
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    58716-433-04118 mL in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 58716-433-16?

    The NDC Packaged Code 58716-433-16 is assigned to a package of 473 ml in 1 bottle of Obredon, a human prescription drug labeled by Sovereign Pharmaceuticals, Llc. The product's dosage form is solution and is administered via oral form.

    Is NDC 58716-433 included in the NDC Directory?

    Yes, Obredon with product code 58716-433 is active and included in the NDC Directory. The product was first marketed by Sovereign Pharmaceuticals, Llc on December 30, 2014 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 11-digit format for NDC 58716-433-16?

    The 11-digit format is 58716043316. 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 5-3-2 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
    5-3-258716-433-165-4-258716-0433-16