Brontuss
NDC Package 49963-381-01

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.

Brontuss is do not exceed recommended dosage.Adults and Children 12years of ageand over:1 teaspoonful (5 mL)every 4 hours, not toexceed 6 doses in 24hours.Children 6 tounder 12years of age:1/2 teaspoonful (2.5 mL)every 4 hours, not toexceed 6 doses in 24hours.Children under 6 yearsof age:Consult a doctor. Marketed by Portal Pharmaceutical, this product is identified by NDC 49963-381 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
49963-381-01
Package Description
30 mL in 1 BOTTLE
Product Code
49963-381
11-Digit Billing Format
49963038101
RxNorm Crosswalk
  • RxCUI: 1251031 - dextromethorphan HBr 15 MG / guaiFENesin 300 MG / phenylephrine HCl 10 MG in 5 mL Oral Solution
  • RxCUI: 1251031 - dextromethorphan hydrobromide 3 MG/ML / guaifenesin 60 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution
  • RxCUI: 1251031 - dextromethorphan HBr 15 MG / guaifenesin 300 MG / phenylephrine HCl 10 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Brontuss Sf-nr
Dosage Form
-
Usage Information
Do not exceed recommended dosage.Adults and Children 12years of ageand over:1 teaspoonful (5 mL)every 4 hours, not toexceed 6 doses in 24hours.Children 6 tounder 12years of age:1/2 teaspoonful (2.5 mL)every 4 hours, not toexceed 6 doses in 24hours.Children under 6 yearsof age:Consult a doctor.

Regulatory & Marketing

Labeler Name
Portal Pharmaceutical
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
12-22-2011
Listing Expiration
12-31-2017
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 (49963-381). Click a package code to view its specific billing and regulatory data.

49963-381-04
118 mL in 1 BOTTLE

* 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 49963-381-01 identifies a specific commercial package of 30 ml in 1 bottle of Brontuss Sf-nr, labeled by Portal Pharmaceutical. 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 Portal Pharmaceutical on December 22, 2011. The current certification is valid through December 31, 2017.

How is this Portal Pharmaceutical product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49963038101. 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 (5-3-2)
49963-381-01
11-Digit CMS (5-4-2)
49963-0381-01

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