Childrens Cetirizine Hydrochloride Solution
NDC Package 17856-6765-3

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 hcl) solution is cetirizine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, sneezing, hives, and itching. This formulation utilizes a solution delivery system. Marketed by Atlantic Biologicals Corp., this product is identified by NDC 17856-6765 and is authorized under FDA application ANDA204226.

Identification & Billing

NDC Package Code
17856-6765-3
Package Description
120 SYRINGE in 1 CASE / 2.5 mL in 1 SYRINGE
Product Code
17856-6765
11-Digit Billing Format
17856676503
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Childrens Cetirizine Hydrochloride
Non-Proprietary Name
Cetirizine Hcl
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
Cetirizine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, sneezing, hives, and itching. It works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Cetirizine does not prevent hives or prevent/treat a serious allergic reaction (such as anaphylaxis). Therefore, if your doctor has prescribed epinephrine to treat allergic reactions, always carry your epinephrine injector with you. Do not use cetirizine in place of your epinephrine.

Regulatory & Marketing

Labeler Name
Atlantic Biologicals Corp.
Product Type
Human Otc Drug
FDA Application #
ANDA204226
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-22-2018
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 (17856-6765). Click a package code to view its specific billing and regulatory data.

17856-6765-1
72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE / 5 mL in 1 CUP, UNIT-DOSE (17856-6765-2)

* 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 17856-6765-3 identifies a specific commercial package of 120 syringe in 1 case / 2.5 ml in 1 syringe of Childrens Cetirizine Hydrochloride, a human over the counter drug labeled by Atlantic Biologicals Corp.. 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 Atlantic Biologicals Corp. on August 22, 2018. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Cetirizine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, sneezing, hives, and itching. It works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Cetirizine does not prevent hives or prevent/treat a serious allergic reaction (such as anaphylaxis). Therefore, if your doctor has prescribed epinephrine to treat allergic reactions, always carry your epinephrine injector with you. Do not use cetirizine in place of your epinephrine.

How is this Atlantic Biologicals Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856676503. 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)
17856-6765-3
11-Digit CMS (5-4-2)
17856-6765-03

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