Topcare Cough Dm Suspension
NDC Package 36800-552-28

11-digit billing NDC: 36800055228 · Billing unit: ML · 148 ML per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Topcare Cough Dm (dextromethorphan polistirex) suspension is •shake bottle well before use•measure only with dosing cup provided•do not use dosing cup with other products•dose as follows or as directed by doctoradults and children 12 years of age and over10 mL every 12 hours, not to exceed 20 mL in 24 hourschildren 6 to under 12 years of age5 mL every 12 hours, not to exceed 10 mL in 24 hourschildren 4 to under 6 years of age2.5 mL every 12 hours, not to exceed 5 mL in 24 hourschildren under 4 years of agedo not use. This formulation utilizes a suspension delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 36800-552 and is authorized under FDA application ANDA091135.

Identification & Billing

NDC Package Code
36800-552-28
Package Description
1 BOTTLE in 1 CARTON / 148 mL in 1 BOTTLE
Product Code
36800-552
11-Digit Billing Format
36800055228
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
148 ML
RxNorm Crosswalk
  • RxCUI: 1373045 - dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral Suspension
  • RxCUI: 1373045 - 12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension
  • RxCUI: 1373045 - dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension
  • RxCUI: 1373045 - dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension

Clinical Specifications

Proprietary Name
Topcare Cough Dm
Non-Proprietary Name
Dextromethorphan Polistirex
Substance Name
Dextromethorphan Hydrobromide
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL
Pharmacologic Class
Usage Information
•shake bottle well before use•measure only with dosing cup provided•do not use dosing cup with other products•dose as follows or as directed by doctoradults and children 12 years of age and over10 mL every 12 hours, not to exceed 20 mL in 24 hourschildren 6 to under 12 years of age5 mL every 12 hours, not to exceed 10 mL in 24 hourschildren 4 to under 6 years of age2.5 mL every 12 hours, not to exceed 5 mL in 24 hourschildren under 4 years of agedo not use

Regulatory & Marketing

Labeler Name
Topco Associates Llc
Product Type
Human Otc Drug
FDA Application #
ANDA091135
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-30-2012
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (36800-552). Click a package code to view its specific billing and regulatory data.

36800-552-21
1 BOTTLE in 1 CARTON / 89 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 36800-552-28 identifies a specific commercial package of 1 bottle in 1 carton / 148 ml in 1 bottle of Topcare Cough Dm, a human over the counter drug labeled by Topco Associates Llc. This suspension is formulated for oral use and contains 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 Topco Associates Llc on August 30, 2012. The current certification is valid through December 31, 2027.

How is this Topco Associates Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800055228. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 148 total billable units per package. 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)
36800-552-28
11-Digit CMS (5-4-2)
36800-0552-28

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