Levocetirizine Dihydrochloride Tablet, Film Coated
NDC Package 69230-321-01

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

Levocetirizine Dihydrochloride 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, film coated delivery system. Marketed by Camber Consumer Care Inc, this product is identified by NDC 69230-321 and is authorized under FDA application ANDA213513.

Identification & Billing

NDC Package Code
69230-321-01
Package Description
10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
69230-321
11-Digit Billing Format
69230032101
RxNorm Crosswalk
  • RxCUI: 855172 - levocetirizine dihydrochloride 5 MG Oral Tablet
  • RxCUI: 855172 - levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet

Clinical Specifications

Proprietary Name
Levocetirizine Dihydrochloride
Non-Proprietary Name
Levocetirizine Dihydrochloride
Substance Name
Levocetirizine Dihydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
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
Camber Consumer Care Inc
Product Type
Human Otc Drug
FDA Application #
ANDA213513
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-28-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69230-321). Click a package code to view its specific billing and regulatory data.

69230-321-10
1000 TABLET, FILM COATED in 1 BOTTLE
69230-321-31
1 BOTTLE in 1 CARTON / 35 TABLET, FILM COATED in 1 BOTTLE
69230-321-32
1 BOTTLE in 1 CARTON / 55 TABLET, FILM COATED in 1 BOTTLE
69230-321-33
1 BOTTLE in 1 CARTON / 80 TABLET, FILM COATED in 1 BOTTLE
69230-321-34
1 BOTTLE in 1 CARTON / 180 TABLET, FILM COATED in 1 BOTTLE
69230-321-36
10000 TABLET, FILM COATED in 1 BAG

* 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 69230-321-01 identifies a specific commercial package of 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack of Levocetirizine Dihydrochloride, a human over the counter drug labeled by Camber Consumer Care Inc. This tablet, film coated 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 Camber Consumer Care Inc on October 28, 2020. 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 Camber Consumer Care Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69230032101. 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)
69230-321-01
11-Digit CMS (5-4-2)
69230-0321-01

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