Lotrel Capsule
NDC Package 0078-0364-05

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Lotrel (amlodipine besylate and benazepril hydrochloride) capsules is a medication a combination of two drugs: a calcium channel blocker (amlodipine) and an ACE inhibitor (benazepril). This formulation utilizes a capsule delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0364 and is authorized under FDA application NDA020364.

Identification & Billing

NDC Package Code
0078-0364-05
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
0078-0364
11-Digit Billing Format
00078036405
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
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: 898344 - Lotrel 10 MG / 20 MG Oral Capsule

Clinical Specifications

Proprietary Name
Lotrel
Non-Proprietary Name
Amlodipine Besylate And Benazepril Hydrochloride
Substance Name
Amlodipine Besylate; Benazepril Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This product is a combination of two drugs: a calcium channel blocker (amlodipine) and an ACE inhibitor (benazepril). It is used to treat high blood pressure. It works by relaxing blood vessels so that blood can flow more easily. Lowering high blood pressure helps prevent strokes, heart attacks and kidney problems.

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA020364
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-03-1995
End Marketing Date
09-30-2026
Exclude Flag
N
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 0078-0364-05 identifies a specific commercial package of 100 capsule in 1 bottle of Lotrel, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. This capsule is formulated for oral use and contains amlodipine besylate; benazepril hydrochloride 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 Novartis Pharmaceuticals Corporation on March 03, 1995.

What are the primary indications for this medication?

This product is a combination of two drugs: a calcium channel blocker (amlodipine) and an ACE inhibitor (benazepril). It is used to treat high blood pressure. It works by relaxing blood vessels so that blood can flow more easily. Lowering high blood pressure helps prevent strokes, heart attacks and kidney problems.

How is this Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078036405. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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:

10-Digit Format (4-4-2)
0078-0364-05
11-Digit CMS (5-4-2)
00078-0364-05

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