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  5. NDC Package Code: 65862-583-01 Amlodipine And Benazepril Hydrochloride

NDC Package 65862-583-01 Amlodipine And Benazepril Hydrochloride

Capsule 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:
65862-583-01
Package Description:
100 CAPSULE in 1 BOTTLE
Product Code:
65862-583
Proprietary Name:
Amlodipine And Benazepril Hydrochloride
Non-Proprietary Name:
Amlodipine And Benazepril Hydrochloride
Substance Name:
Amlodipine Besylate; Benazepril Hydrochloride
Usage Information:
Do not coadminister aliskiren with angiotensin receptor blockers (ARBs), ACE inhibitors, including amlodipine and benazepril hydrochloride capsules in patients with diabetes.Amlodipine and benazepril hydrochloride capsules  are contraindicated in patients with a history of angioedema, with or without previous ACE inhibitor treatment, or patients who are hypersensitive to benazepril, to any other ACE inhibitor, to amlodipine, or to any of the excipients of amlodipine and benazepril hydrochloride capsules.Amlodipine and benazepril hydrochloride capsules are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer amlodipine and benazepril hydrochloride capsules within 36 hours of switching to or from a neprilysin inhibitor, e.g., sacubitril/valsartan [see Warnings and Precautions (5.1)]
11-Digit NDC Billing Format:
65862058301
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 898342 - amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral Capsule
  • RxCUI: 898342 - amlodipine 10 MG / benazepril hydrochloride 20 MG Oral Capsule
  • RxCUI: 898342 - amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral Capsule
  • RxCUI: 898342 - Amlodipine 10 MG / BZP hydrochloride 20 MG Oral Capsule
  • RxCUI: 898346 - amLODIPine besylate 10 MG / benazepril HCl 40 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Aurobindo Pharma Limited
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • AMLODIPINE BESYLATE 5 mg/1
  • BENAZEPRIL HYDROCHLORIDE 10 mg/1
  • AMLODIPINE BESYLATE 5 mg/1
  • BENAZEPRIL HYDROCHLORIDE 10 mg/1
    • Pharmacologic Class(es):
  • Angiotensin Converting Enzyme Inhibitor - [EPC] (Established Pharmacologic Class)
  • Angiotensin-converting Enzyme Inhibitors - [MoA] (Mechanism of Action)
  • Calcium Channel Antagonists - [MoA] (Mechanism of Action)
  • Decreased Blood Pressure - [PE] (Physiologic Effect)
  • Dihydropyridine Calcium Channel Blocker - [EPC] (Established Pharmacologic Class)
  • Dihydropyridines - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA202239
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-05-2012
    Listing Expiration Date:
    12-31-2024
    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
    65862-583-05500 CAPSULE in 1 BOTTLE
    65862-583-222000 CAPSULE in 1 BAG

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65862-583-01?

    The NDC Packaged Code 65862-583-01 is assigned to a package of 100 capsule in 1 bottle of Amlodipine And Benazepril Hydrochloride, a human prescription drug labeled by Aurobindo Pharma Limited. The product's dosage form is capsule and is administered via oral form.

    Is NDC 65862-583 included in the NDC Directory?

    Yes, Amlodipine And Benazepril Hydrochloride with product code 65862-583 is active and included in the NDC Directory. The product was first marketed by Aurobindo Pharma Limited on September 05, 2012 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 65862-583-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

    What is the 11-digit format for NDC 65862-583-01?

    The 11-digit format is 65862058301. 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
    5-3-265862-583-015-4-265862-0583-01