Valsartan Tablet, Film Coated
NDC Package 81033-107-01

11-digit billing NDC: 81033010701
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Valsartan tablets is do not use in patients with known hypersensitivity to any component. Do not coadminister aliskiren with valsartan tablets in patients with diabetes [see Drug Interactions ( 7.3)]. This formulation utilizes a tablet, film coated delivery system. Marketed by Kesin Pharma Corporation, this product is identified by NDC 81033-107 and is authorized under FDA application ANDA205536.

Identification & Billing

NDC Package Code
81033-107-01
Package Description
10 BLISTER PACK in 1 CARTON / 100 TABLET, FILM COATED in 1 BLISTER PACK (81033-107-80)
Product Code
81033-107
11-Digit Billing Format
81033010701

Clinical Specifications

Proprietary Name
Valsartan
Non-Proprietary Name
Valsartan
Substance Name
Valsartan
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
VALSARTAN 80 mg/1
Pharmacologic Class
Usage Information
Do not use in patients with known hypersensitivity to any component. Do not coadminister aliskiren with valsartan tablets in patients with diabetes [see Drug Interactions ( 7.3)].

Regulatory & Marketing

Labeler Name
Kesin Pharma Corporation
Product Type
Human Prescription Drug
FDA Application #
ANDA205536
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-14-2019
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 81033-107-01 identifies a specific commercial package of 10 blister pack in 1 carton / 100 tablet, film coated in 1 blister pack (81033-107-80) of Valsartan, a human prescription drug labeled by Kesin Pharma Corporation. This tablet, film coated is formulated for oral use and contains valsartan 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 Kesin Pharma Corporation on March 14, 2019. The current certification is valid through December 31, 2027.

How is this Kesin Pharma Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81033010701. 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)
81033-107-01
11-Digit CMS (5-4-2)
81033-0107-01

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