Robafen Dm
NDC Package 17856-6759-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Robafen Dm is •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 children12 years and over10 mLevery 4 hourschildren under 12 yearsdo not use. Marketed by Atlantic Biologicals Corp., this product is identified by NDC 17856-6759 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
17856-6759-2
Package Description
72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE / 5 mL in 1 CUP, UNIT-DOSE
Product Code
17856-6759
11-Digit Billing Format
17856675902
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

Clinical Specifications

Proprietary Name
Robafen Dm
Dosage Form
-
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 children12 years and over10 mLevery 4 hourschildren under 12 yearsdo not use

Regulatory & Marketing

Labeler Name
Atlantic Biologicals Corp.
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
12-19-2018
Listing Expiration
12-31-2019
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (17856-6759). Click a package code to view its specific billing and regulatory data.

17856-6759-1
72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE / 10 mL in 1 CUP, UNIT-DOSE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 17856-6759-2 identifies a specific commercial package of 72 cup, unit-dose in 1 box, unit-dose / 5 ml in 1 cup, unit-dose of Robafen Dm, labeled by Atlantic Biologicals Corp.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Atlantic Biologicals Corp. on December 19, 2018. The current certification is valid through December 31, 2019.

How is this Atlantic Biologicals Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856675902. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
17856-6759-2
11-Digit CMS (5-4-2)
17856-6759-02

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.