Zyrtec Allergy Capsule, Liquid Filled
NDC Package 50580-786-40

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) capsules is adults and children 6 years and overone 10 mg capsule once daily; do not take more than one 10 mg capsule in 24 hours. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Kenvue Brands Llc, this product is identified by NDC 50580-786 and is authorized under FDA application ANDA213105.

Identification & Billing

NDC Package Code
50580-786-40
Package Description
1 BOTTLE in 1 PACKAGE / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
Product Code
50580-786
11-Digit Billing Format
50580078640
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zyrtec Allergy
Non-Proprietary Name
Cetirizine Hydrochloride
Substance Name
Cetirizine Hydrochloride
Dosage Form
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
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 overone 10 mg capsule once daily; do not take more than one 10 mg capsule 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 #
ANDA213105
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-15-2024
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 (50580-786). Click a package code to view its specific billing and regulatory data.

50580-786-12
1 BOTTLE in 1 PACKAGE / 12 CAPSULE, LIQUID FILLED in 1 BOTTLE
50580-786-13
1 BOTTLE in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BOTTLE
50580-786-25
1 BOTTLE in 1 PACKAGE / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE
50580-786-26
1 BOTTLE in 1 CARTON / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE
50580-786-41
1 BOTTLE in 1 CARTON / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
50580-786-65
65 CAPSULE, LIQUID FILLED in 1 PACKAGE, COMBINATION
50580-786-66
65 CAPSULE, LIQUID FILLED in 1 PACKAGE

* 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 50580-786-40 identifies a specific commercial package of 1 bottle in 1 package / 40 capsule, liquid filled in 1 bottle of Zyrtec Allergy, a human over the counter drug labeled by Kenvue Brands Llc. This capsule, liquid filled 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 April 15, 2024. 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: 50580078640. 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)
50580-786-40
11-Digit CMS (5-4-2)
50580-0786-40

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