Defensolito Children Syrup
NDC Package 53145-008-04

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

Package Information

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

Defensolito Children Syrup is do not exceed 6 doses in 24 hours Age Dose Children 6 to under 12 years of age  1 tablespoonful (15mL) every 4 hours Children 2 to under 6 years of age  1/2 tablespoonful (7.5 mL) every 4 hours  Children under 2 years of age  consult your doctor. Marketed by Menper Distributors, Inc., this product is identified by NDC 53145-008 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
53145-008-04
Package Description
1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE
Product Code
53145-008
11-Digit Billing Format
53145000804
RxNorm Crosswalk
  • RxCUI: 1298228 - dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 15 mL Oral Solution
  • RxCUI: 1298228 - dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 6.67 MG/ML Oral Solution
  • RxCUI: 1298228 - dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 15 ML Oral Solution
  • RxCUI: 1298228 - dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 30 ML Oral Solution

Clinical Specifications

Proprietary Name
Defensolito Children Syrup
Dosage Form
-
Usage Information
Do not exceed 6 doses in 24 hours Age Dose Children 6 to under 12 years of age  1 tablespoonful (15mL) every 4 hours Children 2 to under 6 years of age  1/2 tablespoonful (7.5 mL) every 4 hours  Children under 2 years of age  consult your doctor

Regulatory & Marketing

Labeler Name
Menper Distributors, 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
02-21-2012
Listing Expiration
12-31-2023
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 53145-008-04 identifies a specific commercial package of 1 bottle in 1 carton / 120 ml in 1 bottle of Defensolito Children Syrup, labeled by Menper Distributors, 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 Menper Distributors, Inc. on February 21, 2012. The current certification is valid through December 31, 2023.

How is this Menper Distributors, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53145000804. 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)
53145-008-04
11-Digit CMS (5-4-2)
53145-0008-04

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