Olmesartan Medoxomil
NDC Package 65162-080-09
Package Information
Olmesartan Medoxomil is olmesartan is used to treat high blood pressure (hypertension). Marketed by Amneal Pharmaceuticals Llc, this product is identified by NDC 65162-080 and is authorized under FDA application ANDA207480.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 65162 - Amneal Pharmaceuticals Llc
- 65162-080 - Olmesartan Medoxomil
- 65162-080-09 - 90 TABLET, FILM COATED in 1 BOTTLE
- 65162-080 - Olmesartan Medoxomil
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 (65162-080). Click a package code to view its specific billing and regulatory data.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 65162-080-09 identifies a specific commercial package of 90 tablet, film coated in 1 bottle of Olmesartan Medoxomil, labeled by Amneal Pharmaceuticals Llc. 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 Amneal Pharmaceuticals Llc on July 19, 2023. The current certification is valid through January 14, 2026.
What are the primary indications for this medication?
Olmesartan is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Olmesartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). It works by relaxing blood vessels so that blood can flow more easily.
How is this Amneal Pharmaceuticals Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 65162008009. 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.