Broncochem Syrup
NDC Package 65131-418-09

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

Package Information

Broncochem (chlorpheniramine maleate-dextromethrophan hbr) syrups is take only as directed, for your convenience a dosage spoon is providedDo not exceed 4 doses in a 24-hour periodChildren from 6 to 12 years-----10mL or cc every 6 hoursChildren fron 2 to 6 years-------5mL or cc every 6 hoursChildren under 2 years, ask your doctor. This formulation utilizes a syrup delivery system. Marketed by Laboratorio Magancehm International Srl, this product is identified by NDC 65131-418 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
65131-418-09
Package Description
1 BOTTLE, PLASTIC in 1 BOX / 120 mL in 1 BOTTLE, PLASTIC
Product Code
65131-418
11-Digit Billing Format
65131041809
RxNorm Crosswalk
  • RxCUI: 636568 - chlorpheniramine maleate 1 MG / dextromethorphan HBr 5 MG in 5 mL Oral Solution
  • RxCUI: 636568 - chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution
  • RxCUI: 636568 - chlorpheniramine maleate 1 MG / dextromethorphan HBr 5 MG per 5 ML Oral Solution
  • RxCUI: 636568 - chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG per 10 ML Oral Solution

Clinical Specifications

Proprietary Name
Broncochem Kids Allergy Control
Non-Proprietary Name
Chlorpheniramine Maleate-dextromethrophan Hbr
Substance Name
Chlorpheniramine Maleate; Dextromethorphan Hydrobromide
Dosage Form
Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Take only as directed, for your convenience a dosage spoon is providedDo not exceed 4 doses in a 24-hour periodChildren from 6 to 12 years-----10mL or cc every 6 hoursChildren fron 2 to 6 years-------5mL or cc every 6 hoursChildren under 2 years, ask your doctor

Regulatory & Marketing

Labeler Name
Laboratorio Magancehm International Srl
Product Type
Human Otc Drug
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
05-01-2017
Listing Expiration
12-31-2026
Exclude Flag
N
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 65131-418-09 identifies a specific commercial package of 1 bottle, plastic in 1 box / 120 ml in 1 bottle, plastic of Broncochem Kids Allergy Control, a human over the counter drug labeled by Laboratorio Magancehm International Srl. This syrup is formulated for oral use and contains chlorpheniramine maleate; dextromethorphan hydrobromide as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Laboratorio Magancehm International Srl on May 01, 2017. The current certification is valid through December 31, 2026.

How is this Laboratorio Magancehm International Srl product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65131041809. 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)
65131-418-09
11-Digit CMS (5-4-2)
65131-0418-09

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