Topcare Allergy And Congestion Relief Tablet, Extended Release
NDC Package 36800-706-22

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

Package Information

Topcare Allergy And Congestion Relief (loratadine, pseudoephedrine sulfate) tablets is •do not divide, crush, chew or dissolve the tabletadults and children 12 years and over1 tablet daily with a full glass of water; not more than 1 tablet in 24 hourschildren under 12 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor. This formulation utilizes a tablet, extended release delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 36800-706 and is authorized under FDA application ANDA075989.

Identification & Billing

NDC Package Code
36800-706-22
Package Description
15 BLISTER PACK in 1 CARTON / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
36800-706
11-Digit Billing Format
36800070622
RxNorm Crosswalk
  • RxCUI: 1117562 - pseudoephedrine sulfate 240 MG / loratadine 10 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1117562 - 24 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral Tablet
  • RxCUI: 1117562 - loratadine 10 MG / pseudoephedrine sulfate 240 MG 24 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Topcare Allergy And Congestion Relief
Non-Proprietary Name
Loratadine, Pseudoephedrine Sulfate
Substance Name
Loratadine; Pseudoephedrine Sulfate
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
•do not divide, crush, chew or dissolve the tabletadults and children 12 years and over1 tablet daily with a full glass of water; not more than 1 tablet in 24 hourschildren under 12 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor

Regulatory & Marketing

Labeler Name
Topco Associates Llc
Product Type
Human Otc Drug
FDA Application #
ANDA075989
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 36800-706-22 identifies a specific commercial package of 15 blister pack in 1 carton / 1 tablet, extended release in 1 blister pack of Topcare Allergy And Congestion Relief, a human over the counter drug labeled by Topco Associates Llc. This tablet, extended release is formulated for oral use and contains loratadine; pseudoephedrine sulfate 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: 36800070622. 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)
36800-706-22
11-Digit CMS (5-4-2)
36800-0706-22

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