24hr Allergy Relief Tablet, Coated
NDC Package 70000-0362-2

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

24hr Allergy Relief (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, coated delivery system. Marketed by Leader/ Cardinal Health 110, Inc., this product is identified by NDC 70000-0362 and is authorized under FDA application ANDA210375.

Identification & Billing

NDC Package Code
70000-0362-2
Package Description
1 BOTTLE in 1 CARTON / 35 TABLET, COATED in 1 BOTTLE
Product Code
70000-0362
11-Digit Billing Format
70000036202
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 855172 - levocetirizine dihydrochloride 5 MG Oral Tablet
  • RxCUI: 855172 - levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet

Clinical Specifications

Proprietary Name
24hr Allergy Relief
Non-Proprietary Name
Levocetirizine Dihydrochloride
Substance Name
Levocetirizine Dihydrochloride
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
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
Leader/ Cardinal Health 110, Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA210375
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-12-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70000-0362). Click a package code to view its specific billing and regulatory data.

70000-0362-1
2 BLISTER PACK in 1 CARTON / 5 TABLET, COATED in 1 BLISTER PACK

* 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 70000-0362-2 identifies a specific commercial package of 1 bottle in 1 carton / 35 tablet, coated in 1 bottle of 24hr Allergy Relief, a human over the counter drug labeled by Leader/ Cardinal Health 110, Inc.. This tablet, 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 Leader/ Cardinal Health 110, Inc. on March 12, 2018. 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 Leader/ Cardinal Health 110, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70000036202. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-4-1)
70000-0362-2
11-Digit CMS (5-4-2)
70000-0362-02

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