Cetirizine Hydrochloride Tablet
NDC Package 68071-1964-9

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 over one 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 Nucare Pharmaceuticals, Inc., this product is identified by NDC 68071-1964 and is authorized under FDA application ANDA077829.

Identification & Billing

NDC Package Code
68071-1964-9
Package Description
90 TABLET in 1 BOTTLE
Product Code
68071-1964
11-Digit Billing Format
68071196409
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 over one 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 sever 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
Nucare Pharmaceuticals, Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA077829
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-01-2009
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 (68071-1964). Click a package code to view its specific billing and regulatory data.

68071-1964-1
10 TABLET in 1 BOTTLE
68071-1964-3
30 TABLET in 1 BOTTLE
68071-1964-7
7 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 68071-1964-9 identifies a specific commercial package of 90 tablet in 1 bottle of Cetirizine Hydrochloride, a human over the counter drug labeled by Nucare Pharmaceuticals, Inc.. 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 Nucare Pharmaceuticals, Inc. on October 01, 2009. The current certification is valid through December 31, 2026.

How is this Nucare Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071196409. 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 (5-4-1)
68071-1964-9
11-Digit CMS (5-4-2)
68071-1964-09

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