Clarinex-d 12 Hour Tablet, Extended Release
NDC Package 78206-120-01

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

Package Information

Clarinex-d 12 Hour (desloratadine and pseudoephedrine sulfate) tablets is a medication used to relieve allergy symptoms such as watery eyes, runny/stuffy nose, itching eyes/nose, and sneezing. This formulation utilizes a tablet, extended release delivery system. Marketed by Organon Llc, this product is identified by NDC 78206-120 and is authorized under FDA application NDA021313.

Identification & Billing

NDC Package Code
78206-120-01
Package Description
100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
78206-120
11-Digit Billing Format
78206012001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 1112248 - desloratadine 2.5 MG / pseudoephedrine sulfate 120 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1112248 - 12 HR desloratadine 2.5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral Tablet
  • RxCUI: 1112250 - CLARINEX-D 2.5 MG / 120 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1112250 - 12 HR desloratadine 2.5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral Tablet [Clarinex-D]
  • RxCUI: 1112250 - Clarinex-D (desloratadine 2.5 MG / pseudoephedrine sulfate 120 MG) 12 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Clarinex-d 12 Hour
Non-Proprietary Name
Desloratadine And Pseudoephedrine Sulfate
Substance Name
Desloratadine; 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
This medication is used to relieve allergy symptoms such as watery eyes, runny/stuffy nose, itching eyes/nose, and sneezing. It contains 2 medications: desloratadine and pseudoephedrine. Desloratadine is an antihistamine and works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Pseudoephedrine is a decongestant and works by narrowing the blood vessels in the nose to decrease swelling and congestion. This medication is not recommended for use in children younger than 12 years of age due to the large amount of pseudoephedrine in it.

Regulatory & Marketing

Labeler Name
Organon Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021313
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-01-2021
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 78206-120-01 identifies a specific commercial package of 100 tablet, extended release in 1 bottle, plastic of Clarinex-d 12 Hour, a human prescription drug labeled by Organon Llc. This tablet, extended release is formulated for oral use and contains desloratadine; 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 Organon Llc on June 01, 2021. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to relieve allergy symptoms such as watery eyes, runny/stuffy nose, itching eyes/nose, and sneezing. It contains 2 medications: desloratadine and pseudoephedrine. Desloratadine is an antihistamine and works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Pseudoephedrine is a decongestant and works by narrowing the blood vessels in the nose to decrease swelling and congestion. This medication is not recommended for use in children younger than 12 years of age due to the large amount of pseudoephedrine in it.

How is this Organon Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78206012001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
78206-120-01
11-Digit CMS (5-4-2)
78206-0120-01

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