Amlodipine Besylate And Benazepril Hydrochloride
NDC Package 63629-5366-1

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 Besylate And Benazepril Hydrochloride is do not coadminister aliskiren with angiotensin receptor blockers, ACE inhibitors, including amlodipine besylate and benazepril hydrochloride in patients with diabetes (4)Amlodipine besylate 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, or amlodipine, or to any of the excipients of amlodipine besylate and benazepril hydrochloride. Marketed by Bryant Ranch Prepack, this product is identified by NDC 63629-5366 and is authorized under FDA application ANDA077179.

Identification & Billing

NDC Package Code
63629-5366-1
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
63629-5366
11-Digit Billing Format
63629536601
RxNorm Crosswalk
  • RxCUI: 898359 - amLODIPine besylate 5 MG / benazepril HCl 40 MG Oral Capsule
  • RxCUI: 898359 - amlodipine 5 MG / benazepril hydrochloride 40 MG Oral Capsule
  • RxCUI: 898359 - amlodipine (as amlodipine besylate) 5 MG / benazepril hydrochloride 40 MG Oral Capsule
  • RxCUI: 898359 - Amlodipine 5 MG / BZP hydrochloride 40 MG Oral Capsule

Clinical Specifications

Proprietary Name
Amlodipine Besylate And Benazepril Hydrochloride
Dosage Form
-
Usage Information
Do not coadminister aliskiren with angiotensin receptor blockers, ACE inhibitors, including amlodipine besylate and benazepril hydrochloride in patients with diabetes (4)Amlodipine besylate 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, or amlodipine, or to any of the excipients of amlodipine besylate and benazepril hydrochloride.

Regulatory & Marketing

Labeler Name
Bryant Ranch Prepack
FDA Application #
ANDA077179
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-20-2011
Listing Expiration
12-31-2017
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 63629-5366-1 identifies a specific commercial package of 30 capsule in 1 bottle of Amlodipine Besylate And Benazepril Hydrochloride, labeled by Bryant Ranch Prepack. 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 Bryant Ranch Prepack on July 20, 2011. The current certification is valid through December 31, 2017.

How is this Bryant Ranch Prepack product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63629536601. 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)
63629-5366-1
11-Digit CMS (5-4-2)
63629-5366-01

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