Levocetirizine Dihydrochloride
NDC Package 45802-594-65

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Levocetirizine Dihydrochloride is levocetirizine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, and sneezing. Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 45802-594 and is authorized under FDA application ANDA090229.

Identification & Billing

NDC Package Code
45802-594-65
Package Description
30 TABLET in 1 BOTTLE
Product Code
45802-594
11-Digit Billing Format
45802059465
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA

Clinical Specifications

Proprietary Name
Levocetirizine Dihydrochloride
Dosage Form
-
Usage Information
Levocetirizine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, and sneezing. It is also used to relieve itching and hives. It works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Levocetirizine does not prevent hives or prevent/treat a serious allergic reaction (such as anaphylaxis). If your doctor has prescribed epinephrine to treat allergic reactions, always carry your epinephrine injector with you. Do not use levocetirizine in place of your epinephrine.

Regulatory & Marketing

Labeler Name
Padagis Israel Pharmaceuticals Ltd
FDA Application #
ANDA090229
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-26-2010
End Marketing Date
04-01-2020
Listing Expiration
04-01-2020
Exclude Flag
D
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (45802-594). Click a package code to view its specific billing and regulatory data.

45802-594-01
3 BOTTLE in 1 CARTON / 30 TABLET in 1 BOTTLE
45802-594-75
90 TABLET in 1 BOTTLE
45802-594-75
90 TABLET in 1 BOTTLE
45802-594-87
300 TABLET in 1 BOTTLE
45802-594-87
300 TABLET in 1 BOTTLE

* 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 45802-594-65 identifies a specific commercial package of 30 tablet in 1 bottle of Levocetirizine Dihydrochloride, labeled by Padagis Israel Pharmaceuticals Ltd. 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 Padagis Israel Pharmaceuticals Ltd on November 26, 2010. The current certification is valid through April 01, 2020.

What are the primary indications for this medication?

Levocetirizine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, and sneezing. It is also used to relieve itching and hives. It works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Levocetirizine does not prevent hives or prevent/treat a serious allergic reaction (such as anaphylaxis). If your doctor has prescribed epinephrine to treat allergic reactions, always carry your epinephrine injector with you. Do not use levocetirizine in place of your epinephrine.

How is this Padagis Israel Pharmaceuticals Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45802059465. 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:

10-Digit Format (5-3-2)
45802-594-65
11-Digit CMS (5-4-2)
45802-0594-65

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