G-bronco-d
NDC Package 43913-403-16

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

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

G-bronco-d is do not take more than 6 doses in any 24-hour period.Adults and children 12 years of age and over2 teaspoons every 4 hoursChildren 6 to under 12 years of age1 teaspoon every 4 hoursChildren 2 to under 6 years of age½ teaspoon every 4 hoursChildren under 2 years of ageConsult a physician. Marketed by Mclaren Medical Inc, this product is identified by NDC 43913-403 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
43913-403-16
Package Description
474 mL in 1 BOTTLE
Product Code
11-Digit Billing Format
43913040316
RxNorm Crosswalk
  • RxCUI: 1486140 - dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 10 mL Oral Suspension
  • RxCUI: 1486140 - dextromethorphan hydrobromide 2 MG/ML / guaifenesin 40 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Suspension
  • RxCUI: 1486140 - dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 5 ML Oral Suspension
  • RxCUI: 1486140 - dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 10 ML Oral Suspension

Clinical Specifications

Proprietary Name
G-bronco-d
Dosage Form
-
Usage Information
Do not take more than 6 doses in any 24-hour period.Adults and children 12 years of age and over2 teaspoons every 4 hoursChildren 6 to under 12 years of age1 teaspoon every 4 hoursChildren 2 to under 6 years of age½ teaspoon every 4 hoursChildren under 2 years of ageConsult a physician

Regulatory & Marketing

Labeler Name
Mclaren Medical Inc
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
07-01-2012
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 43913-403-16 identifies a specific commercial package of 474 ml in 1 bottle of G-bronco-d, labeled by Mclaren Medical Inc. 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 Mclaren Medical Inc on July 01, 2012. The current certification is valid through December 31, 2017.

How is this Mclaren Medical Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43913040316. 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)
43913-403-16
11-Digit CMS (5-4-2)
43913-0403-16

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