Clarinex-d 12 Hour
NDC Package 54868-5708-1
Package Information
Clarinex-d 12 Hour is a medication used to relieve allergy symptoms such as watery eyes, runny/stuffy nose, itching eyes/nose, and sneezing. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5708 and is authorized under FDA application NDA021313.
Identification & Billing
- 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
Regulatory & Marketing
Hierarchy Structure
- 54868 - Physicians Total Care, Inc.
- 54868-5708 - Clarinex-d 12 Hour
- 54868-5708-1 - 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
- 54868-5708 - Clarinex-d 12 Hour
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.
Other Available Packages
The following commercial packages are registered under the same Product NDC (54868-5708). Click a package code to view its specific billing and regulatory data.
* 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 54868-5708-1 identifies a specific commercial package of 30 tablet, extended release in 1 bottle, plastic of Clarinex-d 12 Hour, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Physicians Total Care, Inc. on November 29, 2006. The current certification is valid through December 31, 2017.
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 Physicians Total Care, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868570801. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.
