Olmesartan Medoxomil Tablet, Film Coated
NDC Package 82009-075-90

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

Package Information

Olmesartan Medoxomil tablets is olmesartan is used to treat high blood pressure (hypertension). This formulation utilizes a tablet, film coated delivery system. Marketed by Quallent Pharmaceuticals Health Llc, this product is identified by NDC 82009-075 and is authorized under FDA application ANDA204798.

Identification & Billing

NDC Package Code
82009-075-90
Package Description
90 TABLET, FILM COATED in 1 BOTTLE
Product Code
82009-075
11-Digit Billing Format
82009007590
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Olmesartan Medoxomil
Non-Proprietary Name
Olmesartan Medoxomil
Substance Name
Olmesartan Medoxomil
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
OLMESARTAN MEDOXOMIL 40 mg/1
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Quallent Pharmaceuticals Health Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA204798
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-01-2023
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 82009-075-90 identifies a specific commercial package of 90 tablet, film coated in 1 bottle of Olmesartan Medoxomil, a human prescription drug labeled by Quallent Pharmaceuticals Health Llc. This tablet, film coated is formulated for oral use and contains olmesartan medoxomil 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 Quallent Pharmaceuticals Health Llc on August 01, 2023. The current certification is valid through December 31, 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 Quallent Pharmaceuticals Health Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82009007590. 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)
82009-075-90
11-Digit CMS (5-4-2)
82009-0075-90

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