Dye Free Childrens Cetirizine Hydrocholride Solution
NDC Package 68094-004-62

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

Package Information

Dye Free Childrens Cetirizine Hydrocholride (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 Precision Dose, Inc., this product is identified by NDC 68094-004 and is authorized under FDA application ANDA204226.

Identification & Billing

NDC Package Code
68094-004-62
Package Description
3 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-004-59)
Product Code
68094-004
11-Digit Billing Format
68094000462
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dye Free Childrens Cetirizine Hydrocholride
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
Precision Dose, Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA204226
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-26-2016
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 68094-004-62 identifies a specific commercial package of 3 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 ml in 1 cup, unit-dose (68094-004-59) of Dye Free Childrens Cetirizine Hydrocholride, a human over the counter drug labeled by Precision Dose, 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 Precision Dose, Inc. on October 26, 2016. The current certification is valid through December 31, 2026.

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 Precision Dose, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68094000462. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
68094-004-62
11-Digit CMS (5-4-2)
68094-0004-62

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