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  5. NDC Package Code: 65597-113-11 Azor

NDC Package 65597-113-11 Azor

Amlodipine Besylate And Olmesartan Medoxomil Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
65597-113-11
Package Description:
1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code:
65597-113
Proprietary Name:
Azor
Non-Proprietary Name:
Amlodipine Besylate And Olmesartan Medoxomil
Substance Name:
Amlodipine Besylate; Olmesartan Medoxomil
Usage Information:
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).
11-Digit NDC Billing Format:
65597011311
NDC to RxNorm Crosswalk:
  • 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Daiichi Sankyo Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • AMLODIPINE BESYLATE 10 mg/1
  • OLMESARTAN MEDOXOMIL 40 mg/1
    • Pharmacologic Class(es):
  • 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]
    • Sample Package:
    No
    FDA Application Number:
    NDA022100
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    09-26-2007
    End Marketing Date:
    02-28-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    65597-113-077 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
    65597-113-1010 BLISTER PACK in 1 BOX / 10 TABLET, FILM COATED in 1 BLISTER PACK
    65597-113-3030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
    65597-113-9090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65597-113-11?

    The NDC Packaged Code 65597-113-11 is assigned to a package of 1000 tablet, film coated in 1 bottle, plastic of Azor, a human prescription drug labeled by Daiichi Sankyo Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 65597-113 included in the NDC Directory?

    Yes, Azor with product code 65597-113 is active and included in the NDC Directory. The product was first marketed by Daiichi Sankyo Inc. on September 26, 2007.

    What is the 11-digit format for NDC 65597-113-11?

    The 11-digit format is 65597011311. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-265597-113-115-4-265597-0113-11