Members Mark Cetirizine
NDC Package 68196-458-79
Package Information
Members Mark Cetirizine is a . Marketed by Sam's West Inc, this product is identified by NDC 68196-458 and is authorized under FDA application ANDA078336.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 68196 - Sam's West Inc
- 68196-458 - Members Mark Cetirizine
- 68196-458-79 - 400 TABLET, FILM COATED in 1 PACKAGE
- 68196-458 - Members Mark Cetirizine
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.
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Other Available Packages
The following commercial packages are registered under the same Product NDC (68196-458). Click a package code to view its specific billing and regulatory data.
* 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 68196-458-79 identifies a specific commercial package of 400 tablet, film coated in 1 package of Members Mark Cetirizine, labeled by Sam's West Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 400 billable units per package. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Sam's West Inc on March 24, 2008. The current certification is valid through February 01, 2022.
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: 68196045879. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 400 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.