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  5. NDC Package Code: 83335-004-01 Curanex Dm

NDC Package 83335-004-01 Curanex Dm

Dextromethorphan Hydrobromide 20 Mg Guaifenesin 400 Mg Tablet 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:
83335-004-01
Package Description:
1 TABLET in 1 BOTTLE
Product Code:
83335-004
Proprietary Name:
Curanex Dm
Non-Proprietary Name:
Dextromethorphan Hydrobromide 20 Mg Guaifenesin 400 Mg
Substance Name:
Dextromethorphan; Guaifenesin
Usage Information:
Cough Suppressant and Expectorant ■ helps: loosen phlegm (mucus) and thin bronchialsecretions to rid the bronchial passageways ofbothersome mucus and make coughs more productive■ temporarily relieves: ■ cough due to minor throat andbronchial irritation associated with the common cold■ the intensity of coughing ■ the impulse to cough tohelp you get to sleep
11-Digit NDC Billing Format:
83335000401
NDC to RxNorm Crosswalk:
  • RxCUI: 1147685 - dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral Tablet
  • RxCUI: 1147685 - dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral Tablet
  • RxCUI: 1147685 - guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Wittman Pharma, Inc.
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DEXTROMETHORPHAN 20 mg/1
  • GUAIFENESIN 400 mg/1
    • Pharmacologic Class(es):
  • Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
  • Expectorant - [EPC] (Established Pharmacologic Class)
  • Increased Respiratory Secretions - [PE] (Physiologic Effect)
  • Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
  • Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
  • Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    M012
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    11-01-2023
    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.

    Frequently Asked Questions

    What is NDC 83335-004-01?

    The NDC Packaged Code 83335-004-01 is assigned to a package of 1 tablet in 1 bottle of Curanex Dm, a human over the counter drug labeled by Wittman Pharma, Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 83335-004 included in the NDC Directory?

    Yes, Curanex Dm with product code 83335-004 is active and included in the NDC Directory. The product was first marketed by Wittman Pharma, Inc. on November 01, 2023 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 83335-004-01?

    The 11-digit format is 83335000401. 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
    5-3-283335-004-015-4-283335-0004-01