Zyrtec Allergy Kit
NDC Package 50580-752-01

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) kits is adults and children 6 years and overone 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. This formulation utilizes a kit delivery system. Marketed by Kenvue Brands Llc, this product is identified by NDC 50580-752 and is authorized under FDA application NDA019835.

Identification & Billing

NDC Package Code
50580-752-01
Package Description
1 KIT in 1 PACKAGE * 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC * 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-70) / 70 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
50580-752
11-Digit Billing Format
50580075201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zyrtec Allergy
Non-Proprietary Name
Cetirizine Hydrochloride
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Adults and children 6 years and overone 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 overask a doctorchildren under 6 years of ageask a doctorconsumers with liver or kidney diseaseask 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
06-15-2020
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage
  • 50580 - Kenvue Brands Llc
    • 50580-752 - Zyrtec Allergy
      • 50580-752-01 - 1 KIT in 1 PACKAGE * 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC * 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-70) / 70 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

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 50580-752-01 identifies a specific commercial package of 1 kit in 1 package * 1 bottle, plastic in 1 package (50580-726-50) / 50 tablet, film coated in 1 bottle, plastic * 1 bottle, plastic in 1 package (50580-726-70) / 70 tablet, film coated in 1 bottle, plastic of Zyrtec Allergy, a human over the counter drug labeled by Kenvue Brands Llc. This kit is formulated for use and contains 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 June 15, 2020. 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: 50580075201. 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)
50580-752-01
11-Digit CMS (5-4-2)
50580-0752-01

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