Cetirizine Hydrochloride
NDC Package 59746-285-33

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 is ● may be taken with and without waterFor Cetirizine hydrochloride chewable tablets 5 mg adults and children 6 years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.adults 65 years and over1 tablet once a day; do not take more than 1 tablet in 24 hours.children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor For Cetirizine hydrochloride chewable tablets 10 mg 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. Marketed by Jubilant Cadista Pharmaceuticals Inc., this product is identified by NDC 59746-285 and is authorized under FDA application ANDA091116.

Identification & Billing

NDC Package Code
59746-285-33
Package Description
3 BLISTER PACK in 1 CARTON / 10 TABLET, CHEWABLE in 1 BLISTER PACK
Product Code
59746-285
11-Digit Billing Format
59746028533
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cetirizine Hydrochloride
Dosage Form
-
Usage Information
● may be taken with and without waterFor Cetirizine hydrochloride chewable tablets 5 mg adults and children 6 years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.adults 65 years and over1 tablet once a day; do not take more than 1 tablet in 24 hours.children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor For Cetirizine hydrochloride chewable tablets 10 mg 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 severe symptoms. adults 65 years and overask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information:store between 20° to 25° C (68° to 77° F) Phenylketonurics: Contains 1.68 mg Phenylalanine (a component of Aspartame) per 5 mgPhenylketonurics: Contains 3.36 mg Phenylalanine (a component of Aspartame) per 10 mgdo not use if carton is opened or if blister unit is broken.see bottom panel for lot number and expiration date.

Regulatory & Marketing

Labeler Name
Jubilant Cadista Pharmaceuticals Inc.
FDA Application #
ANDA091116
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-19-2015
Listing Expiration
12-31-2022
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 (59746-285). Click a package code to view its specific billing and regulatory data.

59746-285-32
3 BLISTER PACK in 1 CARTON / 10 TABLET, CHEWABLE in 1 BLISTER PACK

* 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 59746-285-33 identifies a specific commercial package of 3 blister pack in 1 carton / 10 tablet, chewable in 1 blister pack of Cetirizine Hydrochloride, labeled by Jubilant Cadista Pharmaceuticals 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 Jubilant Cadista Pharmaceuticals Inc. on February 19, 2015. The current certification is valid through December 31, 2022.

How is this Jubilant Cadista Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59746028533. 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)
59746-285-33
11-Digit CMS (5-4-2)
59746-0285-33

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