Levocetirizine Dihydrochloride Solution
NDC Package 45802-680-28

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

Package Information

Levocetirizine Dihydrochloride solution is levocetirizine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, and sneezing. This formulation utilizes a solution delivery system. Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 45802-680 and is authorized under FDA application ANDA091263.

Identification & Billing

NDC Package Code
45802-680-28
Package Description
148 mL in 1 BOTTLE
Product Code
45802-680
11-Digit Billing Format
45802068028
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
148 ML
RxNorm Crosswalk
  • RxCUI: 855168 - levocetirizine dihydrochloride 2.5 MG in 5 mL Oral Solution
  • RxCUI: 855168 - levocetirizine dihydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 855168 - levocetirizine dihydrochloride 2.5 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Levocetirizine Dihydrochloride
Non-Proprietary Name
Levocetirizine Dihydrochloride
Substance Name
Levocetirizine Dihydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LEVOCETIRIZINE DIHYDROCHLORIDE .5 mg/mL
Pharmacologic Class
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
Product Type
Human Prescription Drug
FDA Application #
ANDA091263
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-07-2011
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 45802-680-28 identifies a specific commercial package of 148 ml in 1 bottle of Levocetirizine Dihydrochloride, a human prescription drug labeled by Padagis Israel Pharmaceuticals Ltd. This solution is formulated for oral use and contains levocetirizine dihydrochloride 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 Padagis Israel Pharmaceuticals Ltd on November 07, 2011. The current certification is valid through December 31, 2026.

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: 45802068028. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 148 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)
45802-680-28
11-Digit CMS (5-4-2)
45802-0680-28

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