Cetirizine Hydrochloride Tablets,10 Mg Tablet
NDC Package 51655-842-52

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, 10 Mg (cetirizine hydrochloride) tablets is usestemporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat. This formulation utilizes a tablet delivery system. Marketed by Northwind Health Company, Llc, this product is identified by NDC 51655-842 and is authorized under FDA application ANDA078933.

Identification & Billing

NDC Package Code
51655-842-52
Package Description
30 TABLET in 1 BOTTLE, PLASTIC
Product Code
51655-842
11-Digit Billing Format
51655084252
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cetirizine Hydrochloride Tablets, 10 Mg
Non-Proprietary Name
Cetirizine Hydrochloride
Substance Name
Cetirizine Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CETIRIZINE HYDROCHLORIDE 10 mg/1
Pharmacologic Class
Usage Information
Usestemporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat

Regulatory & Marketing

Labeler Name
Northwind Health Company, Llc
Product Type
Human Otc Drug
FDA Application #
ANDA078933
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-07-2023
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 (51655-842). Click a package code to view its specific billing and regulatory data.

51655-842-26
90 TABLET in 1 BOTTLE, PLASTIC
51655-842-60
100 TABLET in 1 BOTTLE, PLASTIC
51655-842-84
14 TABLET in 1 BOTTLE, PLASTIC

* 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 51655-842-52 identifies a specific commercial package of 30 tablet in 1 bottle, plastic of Cetirizine Hydrochloride Tablets, 10 Mg, a human over the counter drug labeled by Northwind Health Company, Llc. This tablet 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 Northwind Health Company, Llc on February 07, 2023. The current certification is valid through December 31, 2027.

How is this Northwind Health Company, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51655084252. 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)
51655-842-52
11-Digit CMS (5-4-2)
51655-0842-52

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