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  5. NDC Package Code: 83335-101-16 Curatussin

NDC Package 83335-101-16 Curatussin

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:
83335-101-16
Package Description:
473 mL in 1 BOTTLE, PLASTIC
Product Code:
83335-101
Proprietary Name:
Curatussin
Non-Proprietary Name:
Guaifenesin
Substance Name:
Guaifenesin
Usage Information:
This medication is used for the temporary relief of coughs caused by the common cold, bronchitis, and other breathing illnesses. This product is usually not used for ongoing cough from smoking or long-term breathing problems (such as chronic bronchitis, emphysema) unless directed by your doctor. Guaifenesin is an expectorant. It works by thinning and loosening mucus in the airways, clearing congestion, and making breathing easier. If you are self-treating with this medication, it is important to read the package instructions carefully before you start using this product to be sure it is right for you. (See also Precautions section.) Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. This product (sustained-release) is not recommended for use in children younger than 12 years unless specifically directed by the doctor. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold. To decrease the risk for side effects, carefully follow all dosage directions. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).
11-Digit NDC Billing Format:
83335010116
NDC to RxNorm Crosswalk:
  • RxCUI: 310604 - guaiFENesin 100 MG in 5 mL Oral Solution
  • RxCUI: 310604 - guaifenesin 20 MG/ML Oral Solution
  • RxCUI: 310604 - guaifenesin 100 MG per 5 ML Oral Solution
  • RxCUI: 310604 - guaifenesin 100 MG per 5 ML Oral Syrup
  • RxCUI: 310604 - guaifenesin 200 MG per 10 ML Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Wittman Pharma, Inc.
    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 100 mg/5mL
    • Pharmacologic Class(es):
  • Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
  • Expectorant - [EPC] (Established Pharmacologic Class)
  • Increased Respiratory Secretions - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    M012
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    01-01-2024
    Listing Expiration Date:
    12-31-2025
    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
    83335-101-04118 mL in 1 BOTTLE, PLASTIC
    83335-101-08237 mL in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 83335-101-16?

    The NDC Packaged Code 83335-101-16 is assigned to a package of 473 ml in 1 bottle, plastic of Curatussin, a human over the counter drug labeled by Wittman Pharma, Inc.. The product's dosage form is solution and is administered via oral form.

    Is NDC 83335-101 included in the NDC Directory?

    Yes, Curatussin with product code 83335-101 is active and included in the NDC Directory. The product was first marketed by Wittman Pharma, Inc. on January 01, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 83335-101-16?

    The 11-digit format is 83335010116. 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
    5-3-283335-101-165-4-283335-0101-16