Tekturna Hct
NDC Package 0078-0521-35

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Tekturna Hct is a medication used to treat high blood pressure (hypertension). Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0521 and is authorized under FDA application NDA022107.

Identification & Billing

NDC Package Code
0078-0521-35
Package Description
100 BLISTER PACK in 1 PACKAGE / 1 TABLET, FILM COATED in 1 BLISTER PACK (0078-0521-61)
Product Code
0078-0521
11-Digit Billing Format
00078052135

Clinical Specifications

Proprietary Name
Tekturna Hct
Dosage Form
-
Usage Information
This product is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This product contains 2 medications: aliskiren and hydrochlorothiazide. Aliskiren works by relaxing blood vessels so blood can flow more easily. It belongs to a class of drugs known as direct renin inhibitors. Hydrochlorothiazide causes your body to get rid of extra salt and water by making more urine. It is called a "water pill" or diuretic.

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
FDA Application #
NDA022107
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-01-2008
End Marketing Date
01-31-2018
Listing Expiration
01-31-2018
Exclude Flag
D
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 (0078-0521). Click a package code to view its specific billing and regulatory data.

0078-0521-15
30 TABLET, FILM COATED in 1 BOTTLE
0078-0521-34
90 TABLET, FILM COATED 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 0078-0521-35 identifies a specific commercial package of 100 blister pack in 1 package / 1 tablet, film coated in 1 blister pack (0078-0521-61) of Tekturna Hct, labeled by Novartis Pharmaceuticals Corporation. 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 Novartis Pharmaceuticals Corporation on August 01, 2008. The current certification is valid through January 31, 2018.

What are the primary indications for this medication?

This product is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This product contains 2 medications: aliskiren and hydrochlorothiazide. Aliskiren works by relaxing blood vessels so blood can flow more easily. It belongs to a class of drugs known as direct renin inhibitors. Hydrochlorothiazide causes your body to get rid of extra salt and water by making more urine. It is called a "water pill" or diuretic.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078052135. 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)
0078-0521-35
11-Digit CMS (5-4-2)
00078-0521-35

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