Valsartan
NDC Package 45865-101-60

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.

Valsartan is used to treat high blood pressure and heart failure. Marketed by Medsource Pharmaceuticals, this product is identified by NDC 45865-101 and is authorized under FDA application ANDA203536.

Identification & Billing

NDC Package Code
45865-101-60
Package Description
60 TABLET in 1 BOTTLE
Product Code
45865-101
11-Digit Billing Format
45865010160
RxNorm Crosswalk
RxCUI: 349199 - valsartan 80 MG Oral Tablet

Clinical Specifications

Proprietary Name
Valsartan
Dosage Form
-
Usage Information
Valsartan is used to treat high blood pressure and heart failure. It is also used to improve the chance of living longer after a heart attack. In people with heart failure, it may also lower the chance of having to go to the hospital for heart failure. Valsartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). 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
Medsource Pharmaceuticals
FDA Application #
ANDA203536
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-03-2020
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 45865-101-60 identifies a specific commercial package of 60 tablet in 1 bottle of Valsartan, labeled by Medsource Pharmaceuticals. 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 Medsource Pharmaceuticals on July 03, 2020. The current certification is valid through December 31, 2024.

What are the primary indications for this medication?

Valsartan is used to treat high blood pressure and heart failure. It is also used to improve the chance of living longer after a heart attack. In people with heart failure, it may also lower the chance of having to go to the hospital for heart failure. Valsartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). 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 Medsource Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45865010160. 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)
45865-101-60
11-Digit CMS (5-4-2)
45865-0101-60

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