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  5. NDC Package Code: 76162-801-89 Topcare Mucus D

NDC Package 76162-801-89 Topcare Mucus D

Guaifenesin And Pseudoephedrine Hydrochloride Tablet, Multilayer, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Topcare Mucus D
Non-Proprietary Name:
Guaifenesin And Pseudoephedrine Hydrochloride
Substance Name:
Guaifenesin; Pseudoephedrine Hydrochloride
Usage Information:
•do not crush, chew, or break tablet•take with a full glass of water•this product can be administered without regard for timing of meals•adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours•children under 12 years of age: do not use
11-Digit NDC Billing Format:
76162080189
Product Type:
Human Otc Drug
Labeler Name:
Topco Associates Llc
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA214407
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
08-16-2023
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 76162-801-89?

The NDC Packaged Code 76162-801-89 is assigned to a 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. The product's dosage form is tablet, multilayer, extended release and is administered via oral form.

Is NDC 76162-801 included in the NDC Directory?

Yes, Topcare Mucus D with product code 76162-801 is active and included in the NDC Directory. The product was first marketed by Topco Associates Llc on August 16, 2023 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 76162-801-89?

The 11-digit format is 76162080189. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-276162-801-895-4-276162-0801-89