Cetirizine Hydrochloride Oral Solution
NDC Package 83745-185-08

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 Oral Solution solution is perennial Allergic Rhinitis: Cetirizine Hydrochloride Oral Solution, USP is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. This formulation utilizes a solution delivery system. Marketed by Apozeal Pharmaceuticals Inc, this product is identified by NDC 83745-185 and is authorized under FDA application ANDA078870.

Identification & Billing

NDC Package Code
83745-185-08
Package Description
240 mL in 1 BOTTLE
Product Code
83745-185
11-Digit Billing Format
83745018508
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
240 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cetirizine Hydrochloride Oral Solution
Non-Proprietary Name
Cetirizine Hydrochloride Oral Solution
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
Perennial Allergic Rhinitis: Cetirizine Hydrochloride Oral Solution, USP is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing.Chronic Urticaria: Cetirizine Hydrochloride Oral Solution, USP is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.

Regulatory & Marketing

Labeler Name
Apozeal Pharmaceuticals Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA078870
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-20-2024
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 (83745-185). Click a package code to view its specific billing and regulatory data.

83745-185-04
120 mL in 1 BOTTLE
83745-185-16
480 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 83745-185-08 identifies a specific commercial package of 240 ml in 1 bottle of Cetirizine Hydrochloride Oral Solution, a human prescription drug labeled by Apozeal Pharmaceuticals 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 Apozeal Pharmaceuticals Inc on December 20, 2024. The current certification is valid through December 31, 2027.

How is this Apozeal Pharmaceuticals Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83745018508. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 240 total billable units per package. 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)
83745-185-08
11-Digit CMS (5-4-2)
83745-0185-08

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