Cetirizine Hydrochloride
NDC Package 40032-652-30

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Cetirizine Hydrochloride May be taken with or without waterFor Cetirizine Hydrochloride Chewable Tablets, 5 mgadults and children 6 years 1 to 2 tablets once daily depending upon severity of symptoms; do not take and over more than 2 tablets in 24 hours. Marketed by Novel Laboratories, Inc., this product is identified by NDC 40032-652 and is authorized under FDA application ANDA206793.

Identification & Billing

NDC Package Code
40032-652-30
Package Description
3 BLISTER PACK in 1 CARTON / 10 TABLET, CHEWABLE in 1 BLISTER PACK
Product Code
40032-652
11-Digit Billing Format
40032065230
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cetirizine Hydrochloride
Dosage Form
-
Usage Information
May be taken with or without waterFor Cetirizine Hydrochloride Chewable Tablets, 5 mgadults and children 6 years 1 to 2 tablets once daily depending upon severity of symptoms; do not take and over more than 2 tablets in 24 hours. adults 65 years and over 1 tablet once a day; do not take more than 1 tablet in 24 hours children under 6 years of ask a doctor age consumers with liver or ask a doctor kidney disease For Cetirizine Hydrochloride Chewable Tablets, 10 mgadults and children 6 one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A years and over 5 mg product may be appropriate for less severe symptoms. adults 65 years and ask a doctor over children under 6 years of age ask a doctor consumers with liver ask a doctor or kidney disease Other informationstore between 20° to 25°C (68° to 77°F)Do not use if individual blister unit is open or torn

Regulatory & Marketing

Labeler Name
Novel Laboratories, Inc.
FDA Application #
ANDA206793
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-08-2016
Listing Expiration
12-31-2024
Exclude Flag
I
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 (40032-652). Click a package code to view its specific billing and regulatory data.

40032-652-03
1 BOTTLE in 1 CARTON / 30 TABLET, CHEWABLE in 1 BOTTLE
40032-652-10
1000 TABLET, CHEWABLE 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 40032-652-30 identifies a specific commercial package of 3 blister pack in 1 carton / 10 tablet, chewable in 1 blister pack of Cetirizine Hydrochloride, labeled by Novel Laboratories, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Novel Laboratories, Inc. on March 08, 2016. The current certification is valid through December 31, 2024.

How is this Novel Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 40032065230. 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)
40032-652-30
11-Digit CMS (5-4-2)
40032-0652-30

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