1. Home
  2. Labeler Index
  3. Major Pharmaceuticals
  4. 0904-6758
  5. NDC Package Code: 0904-6758-16 Robafen

NDC Package 0904-6758-16 Robafen

Dextromethorphan Hbr,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:
0904-6758-16
Package Description:
473 mL in 1 BOTTLE
Product Code:
0904-6758
Proprietary Name:
Robafen
Non-Proprietary Name:
Dextromethorphan Hbr, Guaifenesin
Substance Name:
Dextromethorphan Hydrobromide; Guaifenesin
Usage Information:
•do not take more than 6 doses in any 24-hour period•measure only with dosing cup provided•keep dosing cup with product•mL = milliliter•this adult product is not intended for use in children under 12 years of ageagedoseadults and children 12 years and over10 mL every 4 hourschildren under 12 yearsdo not use
11-Digit NDC Billing Format:
00904675816
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: 996520 - dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution
  • RxCUI: 996520 - dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution
  • RxCUI: 996520 - dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution
  • RxCUI: 996520 - dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution
  • RxCUI: 996520 - dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Major Pharmaceuticals
    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):
  • DEXTROMETHORPHAN HYDROBROMIDE 20 mg/10mL
  • GUAIFENESIN 200 mg/10mL
    • Pharmacologic Class(es):
  • 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:
    part341
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    08-13-2018
    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
    0904-6758-591 BOTTLE in 1 CARTON / 237 mL in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0904-6758-16?

    The NDC Packaged Code 0904-6758-16 is assigned to a package of 473 ml in 1 bottle of Robafen, a human over the counter drug labeled by Major Pharmaceuticals. The product's dosage form is solution and is administered via oral form.

    Is NDC 0904-6758 included in the NDC Directory?

    Yes, Robafen with product code 0904-6758 is active and included in the NDC Directory. The product was first marketed by Major Pharmaceuticals on August 13, 2018 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 0904-6758-16?

    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 0904-6758-16?

    The 11-digit format is 00904675816. 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 4-4-2 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
    4-4-20904-6758-165-4-200904-6758-16