Topcare Mucus D Tablet, Multilayer, Extended Release
NDC Package 76162-801-89

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

Package Information

Topcare Mucus D (guaifenesin and pseudoephedrine hydrochloride) tablets is classified as a

administered via oral route. This formulation utilizes a tablet, multilayer, extended release delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 76162-801 and is authorized under FDA application ANDA214407.

Identification & Billing

NDC Package Code
76162-801-89
Package Description
18 BLISTER PACK in 1 CARTON / 1 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
76162-801
11-Digit Billing Format
76162080189

Clinical Specifications

Proprietary Name
Topcare Mucus D
Non-Proprietary Name
Guaifenesin And Pseudoephedrine Hydrochloride
Substance Name
Guaifenesin; Pseudoephedrine Hydrochloride
Dosage Form
Tablet, Multilayer, Extended Release - A solid dosage form containing medicinal substances that have been compressed to form a multiple-layered tablet or a tablet-within-a-tablet, the inner tablet being the core and the outer portion being the shell, which, additionally, is covered in a designated coating; the tablet is formulated in such manner as to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class

Regulatory & Marketing

Labeler Name
Topco Associates Llc
Product Type
Human Otc Drug
FDA Application #
ANDA214407
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-16-2023
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 76162-801-89 identifies a specific commercial package of 18 blister pack in 1 carton / 1 tablet, multilayer, extended release in 1 blister pack of Topcare Mucus D, a human over the counter drug labeled by Topco Associates Llc. This tablet, multilayer, extended release is formulated for oral use and contains guaifenesin; pseudoephedrine hydrochloride 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 16, 2023. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76162080189. 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)
76162-801-89
11-Digit CMS (5-4-2)
76162-0801-89

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