Cetirizine Hydrochloride Tablet, Chewable
NDC Package 0781-5283-64

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Cetirizine Hydrochloride tablets is •may be taken with or without wateradults 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 over1 tablet once a day; do not take more than 1 tablet in 24 hourschildren under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor. This formulation utilizes a tablet, chewable delivery system. Marketed by Sandoz Inc, this product is identified by NDC 0781-5283 and is authorized under FDA application ANDA078692.

Identification & Billing

NDC Package Code
0781-5283-64
Package Description
30 BLISTER PACK in 1 CARTON / 1 TABLET, CHEWABLE in 1 BLISTER PACK (0781-5283-06)
Product Code
0781-5283
11-Digit Billing Format
00781528364
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 wateradults 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 over1 tablet once a day; do not take more than 1 tablet in 24 hourschildren under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Regulatory & Marketing

Labeler Name
Sandoz Inc
Product Type
Human Otc Drug
FDA Application #
ANDA078692
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-14-2008
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0781-5283-64 identifies a specific commercial package of 30 blister pack in 1 carton / 1 tablet, chewable in 1 blister pack (0781-5283-06) of Cetirizine Hydrochloride, a human over the counter drug labeled by Sandoz 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 Sandoz Inc on February 14, 2008. The current certification is valid through December 31, 2027.

How is this Sandoz Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00781528364. 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 (4-4-2)
0781-5283-64
11-Digit CMS (5-4-2)
00781-5283-64

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