Amlodipine Besylate Tablet
NDC Package 65841-620-77

11-digit billing NDC: 65841062077
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Amlodipine Besylate tablets is classified as a

administered via oral route. This formulation utilizes a tablet delivery system. Marketed by Zydus Lifesciences Limited, this product is identified by NDC 65841-620 and is authorized under FDA application ANDA078226.

Identification & Billing

NDC Package Code
65841-620-77
Package Description
10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK
Product Code
65841-620
11-Digit Billing Format
65841062077
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Amlodipine Besylate
Non-Proprietary Name
Amlodipine Besylate
Substance Name
Amlodipine Besylate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
AMLODIPINE BESYLATE 2.5 mg/1
Pharmacologic Class

Regulatory & Marketing

Labeler Name
Zydus Lifesciences Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA078226
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-21-2007
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65841-620). Click a package code to view its specific billing and regulatory data.

65841-620-01
100 TABLET in 1 BOTTLE
65841-620-05
500 TABLET in 1 BOTTLE
65841-620-16
90 TABLET in 1 BOTTLE

* 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 65841-620-77 identifies a specific commercial package of 10 blister pack in 1 carton / 10 tablet in 1 blister pack of Amlodipine Besylate, a human prescription drug labeled by Zydus Lifesciences Limited. This tablet is formulated for oral use and contains amlodipine besylate 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 Zydus Lifesciences Limited on September 21, 2007. The current certification is valid through December 31, 2027.

How is this Zydus Lifesciences Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65841062077. 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 (5-3-2)
65841-620-77
11-Digit CMS (5-4-2)
65841-0620-77

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