Goodmeds Levocetirizine Dihydrochloride 5mg 365 Count Tablet
NDC Package 82725-4051-1

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

Package Information

Goodmeds Levocetirizine Dihydrochloride 5mg 365 Count (levocetirizine dihydrochloride 5mg) tablets 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 tablet delivery system. Marketed by Cabinet Health P.b.c., this product is identified by NDC 82725-4051 and is authorized under FDA application ANDA213513.

Identification & Billing

NDC Package Code
82725-4051-1
Package Description
365 TABLET in 1 BOTTLE
Product Code
82725-4051
11-Digit Billing Format
82725405101

Clinical Specifications

Proprietary Name
Goodmeds Levocetirizine Dihydrochloride 5mg 365 Count
Non-Proprietary Name
Levocetirizine Dihydrochloride 5mg
Substance Name
Levocetirizine Dihydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1
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
Cabinet Health P.b.c.
Product Type
Human Otc Drug
FDA Application #
ANDA213513
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-30-2026
Listing Expiration
12-31-2027
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 82725-4051-1 identifies a specific commercial package of 365 tablet in 1 bottle of Goodmeds Levocetirizine Dihydrochloride 5mg 365 Count, a human over the counter drug labeled by Cabinet Health P.b.c.. This tablet 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 Cabinet Health P.b.c. on June 30, 2026. The current certification is valid through December 31, 2027.

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 Cabinet Health P.b.c. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82725405101. 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 (5-4-1)
82725-4051-1
11-Digit CMS (5-4-2)
82725-4051-01

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