Amlodipine And Benazepril Hydrochloride
NDC Package 53002-1782-0

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Amlodipine And Benazepril Hydrochloride is 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). Marketed by Rpk Pharmaceuticals, Inc., this product is identified by NDC 53002-1782 and is authorized under FDA application ANDA202239.

Identification & Billing

NDC Package Code
53002-1782-0
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
53002-1782
11-Digit Billing Format
53002178200
RxNorm Crosswalk
  • RxCUI: 898350 - amLODIPine besylate 2.5 MG / benazepril HCl 10 MG Oral Capsule
  • RxCUI: 898350 - amlodipine 2.5 MG / benazepril hydrochloride 10 MG Oral Capsule
  • RxCUI: 898350 - amlodipine (as amlodipine besylate) 2.5 MG / benazepril HCl 10 MG Oral Capsule
  • RxCUI: 898350 - Amlodipine 2.5 MG / BZP hydrochloride 10 MG Oral Capsule

Clinical Specifications

Proprietary Name
Amlodipine And Benazepril Hydrochloride
Dosage Form
-
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)]

Regulatory & Marketing

Labeler Name
Rpk Pharmaceuticals, Inc.
FDA Application #
ANDA202239
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-05-2012
Listing Expiration
12-31-2024
Exclude Flag
I
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 53002-1782-0 identifies a specific commercial package of 100 capsule in 1 bottle of Amlodipine And Benazepril Hydrochloride, labeled by Rpk Pharmaceuticals, Inc.. 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 Rpk Pharmaceuticals, Inc. on September 05, 2012. The current certification is valid through December 31, 2024.

How is this Rpk Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53002178200. 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 (5-4-1)
53002-1782-0
11-Digit CMS (5-4-2)
53002-1782-00

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