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  4. NDC Product Code: 58716-433 Obredon

NDC 58716-433 Obredon

Hydrocodone Bitartrate And Guaifenesin Solution Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 58716-433?
  5. Obredon Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

NDC Product Code:
58716-433
Proprietary Name:
Obredon
Non-Proprietary Name: [1]
Hydrocodone Bitartrate And Guaifenesin
Substance Name: [2]
Guaifenesin; Hydrocodone Bitartrate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Sovereign Pharmaceuticals, Llc
    Labeler Code:
    58716
    Product Label ID:
    f73fdec5-d330-4d8c-894b-d0bcf5490624
    FDA Application Number: [6]
    NDA205474
    DEA Schedule: [7]
    Schedule II (CII) Substances
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    12-30-2014
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Flavor(s):
    RASPBERRY (C73413)

    Code Structure Chart

    Product Details

    What is NDC 58716-433?

    The NDC code 58716-433 is assigned by the FDA to the product Obredon which is a human prescription drug product labeled by Sovereign Pharmaceuticals, Llc. The generic name of Obredon is hydrocodone bitartrate and guaifenesin. The product's dosage form is solution and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 58716-433-04 118 ml in 1 bottle , 58716-433-16 473 ml in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Obredon?

    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.

    What are Obredon Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • GUAIFENESIN 200 mg/5mL - An expectorant that also has some muscle relaxing action. It is used in many cough preparations.
    • HYDROCODONE BITARTRATE 2.5 mg/5mL - Narcotic analgesic related to CODEINE, but more potent and more addicting by weight. It is used also as cough suppressant.

    Which are Obredon UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Obredon Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Obredon?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • 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

    Which are the Pharmacologic Classes for Obredon?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Guaifenesin


    Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
    [Learn More]


    Hydrocodone Combination Products


    Hydrocodone is available in combination with other ingredients, and different combination products are prescribed for different uses. Some hydrocodone combination products are used to relieve moderate-to-severe pain. Other hydrocodone combination products are used to relieve cough. Hydrocodone is in a class of medications called opiate (narcotic) analgesics and in a class of medications called antitussives. Hydrocodone relieves pain by changing the way the brain and nervous system respond to pain. Hydrocodone relieves cough by decreasing activity in the part of the brain that causes coughing. You will take hydrocodone in combination with at least one other medication, but this monograph only provides information about hydrocodone. Be sure to read information about the other ingredients in the hydrocodone product you are taking. Ask your doctor or pharmacist if you have any questions.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [7] What is the Drug Enforcement Administration (DEA) CII Schedule? - This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".