NDC Package 0078-0485-35 Tekturna

View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is EXCLUDED from the official NDC directory .

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0078-0485-35
Package Description:
100 BLISTER PACK in 1 PACKAGE / 1 TABLET, FILM COATED in 1 BLISTER PACK (0078-0485-61)
Product Code:
Proprietary Name:
Tekturna
Usage Information:
This medication is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Aliskiren works by relaxing blood vessels so blood can flow more easily. It belongs to a class of drugs known as direct renin inhibitors. This drug is not recommended for use in children younger than 2 years due to an increased risk of side effects.
11-Digit NDC Billing Format:
00078048535
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
Labeler Name:
Novartis Pharmaceuticals Corporation
Sample Package:
No
FDA Application Number:
NDA021985
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
03-05-2007
End Marketing Date:
05-31-2018
Listing Expiration Date:
05-31-2018
Exclude Flag:
D
Code Structure:

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
0078-0485-1530 TABLET, FILM COATED in 1 BOTTLE
0078-0485-3490 TABLET, FILM COATED in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0078-0485-35?

The NDC Packaged Code 0078-0485-35 is assigned to a package of 100 blister pack in 1 package / 1 tablet, film coated in 1 blister pack (0078-0485-61) of Tekturna, labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is and is administered via form.

Is NDC 0078-0485 included in the NDC Directory?

The product was first marketed by Novartis Pharmaceuticals Corporation on March 05, 2007 and its listing in the NDC Directory is set to expire on May 31, 2018 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0078-0485-35?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

What is the 11-digit format for NDC 0078-0485-35?

The 11-digit format is 00078048535. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
4-4-20078-0485-355-4-200078-0485-35