Cetirizine Hydrochloride Tablet, Chewable
NDC Package 47335-343-83

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 May be taken with or without waterFor 5 mg:adults and children 6 years and over1 to 2 tablets once daily depending upon severity of symptoms; do not take 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 hourschildren under 6 years of ageask a doctorconsumers with liver or kidney diseaseask a doctorFor 10 mg: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, chewable delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 47335-343 and is authorized under FDA application ANDA090142.

Identification & Billing

NDC Package Code
47335-343-83
Package Description
30 TABLET, CHEWABLE in 1 BOTTLE
Product Code
47335-343
11-Digit Billing Format
47335034383
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, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CETIRIZINE HYDROCHLORIDE 5 mg/1
Pharmacologic Class
Usage Information
May be taken with or without waterFor 5 mg:adults and children 6 years and over1 to 2 tablets once daily depending upon severity of symptoms; do not take 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 hourschildren under 6 years of ageask a doctorconsumers with liver or kidney diseaseask a doctorFor 10 mg: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
Sun Pharmaceutical Industries, Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA090142
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-09-2011
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 (47335-343). Click a package code to view its specific billing and regulatory data.

47335-343-15
30 TABLET, CHEWABLE in 1 BOTTLE
47335-343-16
100 TABLET, CHEWABLE in 1 BOTTLE
47335-343-88
100 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 47335-343-83 identifies a specific commercial package of 30 tablet, chewable in 1 bottle of Cetirizine Hydrochloride, a human over the counter drug labeled by Sun Pharmaceutical Industries, Inc.. This tablet, chewable 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 Sun Pharmaceutical Industries, Inc. on September 09, 2011. The current certification is valid through December 31, 2027.

How is this Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47335034383. 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)
47335-343-83
11-Digit CMS (5-4-2)
47335-0343-83

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