Zyrtec Allergy Cetirizine Hcl Capsule
NDC Package 67414-013-03

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 Hcl (cetirizine hydrochloride) capsules is  adults and children 6 years and over  one 10 mg capsule once daily; do not take more than one 10 mg capsule in 24 hours. This formulation utilizes a capsule delivery system. Marketed by Jones Healthcare Group - Packaging Services, Inc, this product is identified by NDC 67414-013 and is authorized under FDA application ANDA213105.

Identification & Billing

NDC Package Code
67414-013-03
Package Description
1 BOTTLE in 1 CARTON / 40 CAPSULE in 1 BOTTLE
Product Code
67414-013
11-Digit Billing Format
67414001303

Clinical Specifications

Proprietary Name
Zyrtec Allergy Cetirizine Hcl
Non-Proprietary Name
Cetirizine Hydrochloride
Substance Name
Cetirizine Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
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 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 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
Jones Healthcare Group - Packaging Services, Inc
Product Type
Human Otc Drug
FDA Application #
ANDA213105
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-30-2026
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 (67414-013). Click a package code to view its specific billing and regulatory data.

67414-013-01
1 BOTTLE in 1 CARTON / 12 CAPSULE in 1 BOTTLE
67414-013-02
1 BOTTLE in 1 CARTON / 25 CAPSULE in 1 BOTTLE

* 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 67414-013-03 identifies a specific commercial package of 1 bottle in 1 carton / 40 capsule in 1 bottle of Zyrtec Allergy Cetirizine Hcl, a human over the counter drug labeled by Jones Healthcare Group - Packaging Services, Inc. This capsule 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 Jones Healthcare Group - Packaging Services, Inc on June 30, 2026. The current certification is valid through December 31, 2027.

How is this Jones Healthcare Group - Packaging Services, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67414001303. 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)
67414-013-03
11-Digit CMS (5-4-2)
67414-0013-03

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