Cetirizine Hydrochloride Tablet, Chewable
NDC Package 51660-066-30

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 May be taken with or without waterchew or crush tablets completely before swallowingadults and children 6 years and overChew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet (10 mg) in 24 hours. This formulation utilizes a tablet, chewable delivery system. Marketed by Ohm Laboratories Inc., this product is identified by NDC 51660-066 and is authorized under FDA application ANDA090142.

Identification & Billing

NDC Package Code
51660-066-30
Package Description
1 BOTTLE in 1 CARTON / 30 TABLET, CHEWABLE in 1 BOTTLE
Product Code
51660-066
11-Digit Billing Format
51660006630
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 10 mg/1
Pharmacologic Class
Usage Information
May be taken with or without waterchew or crush tablets completely before swallowingadults and children 6 years and overChew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet (10 mg) 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
Ohm Laboratories 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
07-21-2022
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 51660-066-30 identifies a specific commercial package of 1 bottle in 1 carton / 30 tablet, chewable in 1 bottle of Cetirizine Hydrochloride, a human over the counter drug labeled by Ohm Laboratories 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 Ohm Laboratories Inc. on July 21, 2022. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51660006630. 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)
51660-066-30
11-Digit CMS (5-4-2)
51660-0066-30

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