Childrens Cetirizine Hydrochloride Hives Relief Solution
NDC Package 58602-030-26

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 Hives Relief (cetirizine hydrochloride) solution is use only with enclosed dosing cupfind right dose on chart belowmL = milliliteradults and children 6 years and over  1 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 over  1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.children under 6 years of age  ask a doctorconsumers with liver or kidney disease     ask a doctor. This formulation utilizes a solution delivery system. Marketed by Aurohealth Llc, this product is identified by NDC 58602-030 and is authorized under FDA application ANDA090750.

Identification & Billing

NDC Package Code
58602-030-26
Package Description
480 mL in 1 BOTTLE
Product Code
58602-030
11-Digit Billing Format
58602003026
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Childrens Cetirizine Hydrochloride Hives Relief
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 over  1 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 over  1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.children under 6 years of age  ask a doctorconsumers with liver or kidney disease     ask a doctor

Regulatory & Marketing

Labeler Name
Aurohealth Llc
Product Type
Human Otc Drug
FDA Application #
ANDA090750
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-24-2015
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (58602-030). Click a package code to view its specific billing and regulatory data.

58602-030-20
1 BOTTLE in 1 CARTON / 240 mL in 1 BOTTLE
58602-030-24
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 58602-030-26 identifies a specific commercial package of 480 ml in 1 bottle of Childrens Cetirizine Hydrochloride Hives Relief, a human over the counter drug labeled by Aurohealth Llc. 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 Aurohealth Llc on June 24, 2015. The current certification is valid through December 31, 2026.

How is this Aurohealth Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58602003026. 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)
58602-030-26
11-Digit CMS (5-4-2)
58602-0030-26

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