Zyrtec Allergy Tablet, Film Coated
NDC Package 50269-973-01

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

Package Information

Zyrtec Allergy (cetirizine hydrochloride) tablets is  adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours.A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor. This formulation utilizes a tablet, film coated delivery system. Marketed by Jc World Bell Wholesale Co., Inc, this product is identified by NDC 50269-973 and is authorized under FDA application NDA019835.

Identification & Billing

NDC Package Code
50269-973-01
Package Description
20 POUCH in 1 BOX / 1 TABLET, FILM COATED in 1 POUCH
Product Code
50269-973
11-Digit Billing Format
50269097301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zyrtec Allergy
Non-Proprietary Name
Cetirizine Hydrochloride
Substance Name
Cetirizine Hydrochloride
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)
CETIRIZINE HYDROCHLORIDE 10 mg/1
Pharmacologic Class
Usage Information
 adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours.A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Regulatory & Marketing

Labeler Name
Jc World Bell Wholesale Co., Inc
Product Type
Human Otc Drug
FDA Application #
NDA019835
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-27-2018
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 50269-973-01 identifies a specific commercial package of 20 pouch in 1 box / 1 tablet, film coated in 1 pouch of Zyrtec Allergy, a human over the counter drug labeled by Jc World Bell Wholesale Co., Inc. This tablet, film coated is formulated for oral use and contains cetirizine hydrochloride 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 Jc World Bell Wholesale Co., Inc on July 27, 2018. The current certification is valid through December 31, 2026.

How is this Jc World Bell Wholesale Co., Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50269097301. 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)
50269-973-01
11-Digit CMS (5-4-2)
50269-0973-01

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