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  5. NDC Package Code: 78206-120-01 Clarinex-d 12 Hour

NDC Package 78206-120-01 Clarinex-d 12 Hour

Desloratadine And Pseudoephedrine Sulfate Tablet, 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:
78206-120-01
Package Description:
100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code:
78206-120
Proprietary Name:
Clarinex-d 12 Hour
Non-Proprietary Name:
Desloratadine And Pseudoephedrine Sulfate
Substance Name:
Desloratadine; Pseudoephedrine Sulfate
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.
11-Digit NDC Billing Format:
78206012001
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Organon Llc
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DESLORATADINE 2.5 mg/1
  • PSEUDOEPHEDRINE SULFATE 120 mg/1
    • Pharmacologic Class(es):
  • Adrenergic alpha-Agonists - [MoA] (Mechanism of Action)
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • alpha-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA021313
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    06-01-2021
    Listing Expiration Date:
    12-31-2024
    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 78206-120-01?

    The NDC Packaged Code 78206-120-01 is assigned to a package of 100 tablet, extended release in 1 bottle, plastic of Clarinex-d 12 Hour, a human prescription drug labeled by Organon Llc. The product's dosage form is tablet, extended release and is administered via oral form.

    Is NDC 78206-120 included in the NDC Directory?

    Yes, Clarinex-d 12 Hour with product code 78206-120 is active and included in the NDC Directory. The product was first marketed by Organon Llc on June 01, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 78206-120-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

    What is the 11-digit format for NDC 78206-120-01?

    The 11-digit format is 78206012001. 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
    5-3-278206-120-015-4-278206-0120-01