Members Mark Childrens Cetirizine Solution
NDC Package 68196-475-43

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

Package Information

Members Mark Childrens Cetirizine (cetirizine hydrochloride) solution is •use only with enclosed dosing cup•find right dose on chart below•mL = milliliteradults and children 6 years and over5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.adults 65 years and over5 mL once daily; do not take more than 5 mL in 24 hours.children 2 to under 6 years of age2.5 mL once daily. This formulation utilizes a solution delivery system. Marketed by Sam's West Inc, this product is identified by NDC 68196-475 and is authorized under FDA application ANDA204226.

Identification & Billing

NDC Package Code
68196-475-43
Package Description
2 BOTTLE in 1 CARTON / 240 mL in 1 BOTTLE (68196-475-34)
Product Code
68196-475
11-Digit Billing Format
68196047543
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Members Mark Childrens Cetirizine
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 cup•find right dose on chart below•mL = milliliteradults and children 6 years and over5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.adults 65 years and over5 mL once daily; do not take more than 5 mL in 24 hours.children 2 to under 6 years of age2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.children under 2 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor

Regulatory & Marketing

Labeler Name
Sam's West 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
09-23-2024
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 68196-475-43 identifies a specific commercial package of 2 bottle in 1 carton / 240 ml in 1 bottle (68196-475-34) of Members Mark Childrens Cetirizine, a human over the counter drug labeled by Sam's West 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 Sam's West Inc on September 23, 2024. The current certification is valid through December 31, 2026.

How is this Sam's West Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68196047543. 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)
68196-475-43
11-Digit CMS (5-4-2)
68196-0475-43

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