Levocetirizine Dihydrochloride
NDC Package 35356-784-60

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 Lake Erie Medical Dba Quality Care Products Llc, this product is identified by NDC 35356-784 and is authorized under FDA application ANDA090199.

Identification & Billing

NDC Package Code
35356-784-60
Package Description
60 TABLET, FILM COATED in 1 BOTTLE
Product Code
35356-784
11-Digit Billing Format
35356078460

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
Lake Erie Medical Dba Quality Care Products Llc
FDA Application #
ANDA090199
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-06-2011
End Marketing Date
12-31-2014
Listing Expiration
12-31-2014
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 (35356-784). Click a package code to view its specific billing and regulatory data.

35356-784-30
30 TABLET, FILM COATED in 1 BOTTLE
35356-784-90
90 TABLET, FILM COATED 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 35356-784-60 identifies a specific commercial package of 60 tablet, film coated in 1 bottle of Levocetirizine Dihydrochloride, labeled by Lake Erie Medical Dba Quality Care Products Llc. 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 Lake Erie Medical Dba Quality Care Products Llc on September 06, 2011. The current certification is valid through December 31, 2014.

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 Lake Erie Medical Dba Quality Care Products Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 35356078460. 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)
35356-784-60
11-Digit CMS (5-4-2)
35356-0784-60

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