Childrens Cetirizine Hydrochloride Solution
NDC Package 51672-2147-1

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

Childrens Cetirizine Hydrochloride (cetirizine hydrochloride) solution is use only with enclosed dosing cupfind right dose on chart belowmL = milliliteradults and children 6 years and over5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours..adults 65 years and older5 mL once daily; do not take more than 5 mL in 24 hourschildren 2 to under 6 years of age2.5 mL once daily. This formulation utilizes a solution delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 51672-2147 and is authorized under FDA application ANDA090182.

Identification & Billing

NDC Package Code
51672-2147-1
Package Description
1 BOTTLE in 1 CARTON / 240 mL in 1 BOTTLE
Product Code
51672-2147
11-Digit Billing Format
51672214701
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Childrens Cetirizine Hydrochloride
Non-Proprietary Name
Cetirizine Hydrochloride
Substance Name
Cetirizine Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CETIRIZINE HYDROCHLORIDE 1 mg/mL
Pharmacologic Class
Usage Information
Use only with enclosed dosing cupfind right dose on chart belowmL = milliliteradults and children 6 years and over5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours..adults 65 years and older5 mL once daily; do not take more than 5 mL in 24 hourschildren 2 to under 6 years of age2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.children under 2 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 #
ANDA090182
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-20-2025
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 (51672-2147). Click a package code to view its specific billing and regulatory data.

51672-2147-8
1 BOTTLE in 1 CARTON / 120 mL 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 51672-2147-1 identifies a specific commercial package of 1 bottle in 1 carton / 240 ml in 1 bottle of Childrens Cetirizine Hydrochloride, a human over the counter drug labeled by Sun Pharmaceutical Industries, Inc.. This solution 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 March 20, 2025. 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: 51672214701. 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 (5-4-1)
51672-2147-1
11-Digit CMS (5-4-2)
51672-2147-01

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