Azor Tablet, Film Coated
NDC Package 0713-0872-30
Package Information
Azor (amlodipine besylate and olmesartan medoxomil) tablets is a medication used to treat high blood pressure (hypertension). This formulation utilizes a tablet, film coated delivery system. Marketed by Cosette Pharmaceuticals, Inc., this product is identified by NDC 0713-0872 and is authorized under FDA application NDA022100.
Identification & Billing
- RxCUI: 730861 - amLODIPine 10 MG / olmesartan medoxomil 20 MG Oral Tablet
- RxCUI: 730861 - amlodipine 10 MG / olmesartan medoxomil 20 MG Oral Tablet
- RxCUI: 730861 - amlodipine 10 MG (as amlodipine besylate 13.9 MG) / olmesartan medoxomil 20 MG Oral Tablet
- RxCUI: 730866 - amLODIPine 10 MG / olmesartan medoxomil 40 MG Oral Tablet
- RxCUI: 730866 - amlodipine 10 MG / olmesartan medoxomil 40 MG Oral Tablet
Clinical Specifications
- Angiotensin 2 Receptor Antagonists - [MoA] (Mechanism of Action)
- Angiotensin 2 Receptor Blocker - [EPC] (Established Pharmacologic Class)
- Calcium Channel Antagonists - [MoA] (Mechanism of Action)
- Calcium Channel Blocker - [EPC] (Established Pharmacologic Class)
- Cytochrome P450 3A Inhibitors - [MoA] (Mechanism of Action)
- Dihydropyridine Calcium Channel Blocker - [EPC] (Established Pharmacologic Class)
- Dihydropyridines - [CS]
Regulatory & Marketing
Hierarchy Structure
- 0713 - Cosette Pharmaceuticals, Inc.
- 0713-0872 - Azor
- 0713-0872-30 - 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
- 0713-0872 - Azor
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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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 0713-0872-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle, plastic of Azor, a human prescription drug labeled by Cosette Pharmaceuticals, Inc.. This tablet, film coated is formulated for oral use and contains amlodipine besylate; 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 Cosette Pharmaceuticals, Inc. on September 01, 2022. The current certification is valid through December 31, 2026.
What are the primary indications for this medication?
This product is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This product contains 2 medications: amlodipine and olmesartan. They both work by relaxing blood vessels so blood can flow more easily. Amlodipine is a calcium channel blocker and olmesartan is an angiotensin receptor blocker (ARB).
How is this Cosette Pharmaceuticals, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00713087230. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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 Labeler segment to maintain the 5-4-2 structure.