Childrens Cetirizine Hydrochloride Solution
NDC Package 68016-023-43

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

Package Information

Childrens Cetirizine Hydrochloride (cetirizine hydrochloride) solution is use only with enclosed dosing cupadults and children 6 years and over1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.adults 65 years and older1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.children 2 to under 6 years of age1/2 teaspoonful (2.5 mL) once daily. This formulation utilizes a solution delivery system. Marketed by Chain Drug Consortium, Llc (premier Value), this product is identified by NDC 68016-023 and is authorized under FDA application ANDA090182.

Identification & Billing

NDC Package Code
68016-023-43
Package Description
1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE
Product Code
68016-023
11-Digit Billing Format
68016002343
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 5 mg/5mL
Pharmacologic Class
Usage Information
Use only with enclosed dosing cupadults and children 6 years and over1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.adults 65 years and older1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.children 2 to under 6 years of age1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours.children under 2 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor

Regulatory & Marketing

Labeler Name
Chain Drug Consortium, Llc (premier Value)
Product Type
Human Otc Drug
FDA Application #
ANDA090182
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-22-2008
Listing Expiration
12-31-2026
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 68016-023-43 identifies a specific commercial package of 1 bottle in 1 carton / 120 ml in 1 bottle of Childrens Cetirizine Hydrochloride, a human over the counter drug labeled by Chain Drug Consortium, Llc (premier Value). 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 Chain Drug Consortium, Llc (premier Value) on April 22, 2008. The current certification is valid through December 31, 2026.

How is this Chain Drug Consortium, Llc (premier Value) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68016002343. 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)
68016-023-43
11-Digit CMS (5-4-2)
68016-0023-43

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