Cetirizine Hydrochloride Tablet
NDC Package 68016-939-30

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

Cetirizine Hydrochloride tablets 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 tablet delivery system. Marketed by Chain Drug Consortium, Llc, this product is identified by NDC 68016-939 and is authorized under FDA application ANDA077498.

Identification & Billing

NDC Package Code
68016-939-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
68016-939
11-Digit Billing Format
68016093930
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cetirizine Hydrochloride
Non-Proprietary Name
Cetirizine Hydrochloride
Substance Name
Cetirizine Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
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 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
Chain Drug Consortium, Llc
Product Type
Human Otc Drug
FDA Application #
ANDA077498
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-27-2007
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 (68016-939). Click a package code to view its specific billing and regulatory data.

68016-939-54
14 TABLET in 1 BLISTER PACK
68016-939-60
60 TABLET in 1 BOTTLE
68016-939-90
90 TABLET 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 68016-939-30 identifies a specific commercial package of 30 tablet in 1 bottle of Cetirizine Hydrochloride, a human over the counter drug labeled by Chain Drug Consortium, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This tablet 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 Chain Drug Consortium, Llc on December 27, 2007. The current certification is valid through December 31, 2026.

How is this Chain Drug Consortium, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68016093930. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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)
68016-939-30
11-Digit CMS (5-4-2)
68016-0939-30

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