Zyrtec Allergy Tablet, Film Coated
NDC Package 50580-754-35

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

Zyrtec Allergy (cetirizine hydrochloride) tablets is adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10mg) in 24 hours. This formulation utilizes a tablet, film coated delivery system. Marketed by Kenvue Brands Llc, this product is identified by NDC 50580-754 and is authorized under FDA application NDA019835.

Identification & Billing

NDC Package Code
50580-754-35
Package Description
1 BOTTLE in 1 CARTON / 35 TABLET, FILM COATED in 1 BOTTLE
Product Code
50580-754
11-Digit Billing Format
50580075435
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 5 mg/1
Pharmacologic Class
Usage Information
Adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10mg) in 24 hours. adults 65 years and over1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.children under 6 years of ageask a doctorconsumers with liver or kidney disease ask a doctor

Regulatory & Marketing

Labeler Name
Kenvue Brands Llc
Product Type
Human Otc Drug
FDA Application #
NDA019835
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-15-2025
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 (50580-754). Click a package code to view its specific billing and regulatory data.

50580-754-15
15 POUCH in 1 CARTON / 1 TABLET, FILM COATED in 1 POUCH

* 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 50580-754-35 identifies a specific commercial package of 1 bottle in 1 carton / 35 tablet, film coated in 1 bottle of Zyrtec Allergy, a human over the counter drug labeled by Kenvue Brands Llc. 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 Kenvue Brands Llc on February 15, 2025. The current certification is valid through December 31, 2026.

How is this Kenvue Brands Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50580075435. 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)
50580-754-35
11-Digit CMS (5-4-2)
50580-0754-35

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