NDC Package 68084-435-01 Isosorbide Mononitrate

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:
68084-435-01
Package Description:
10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-435-11)
Product Code:
Proprietary Name:
Isosorbide Mononitrate
Usage Information:
Isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition (coronary artery disease). This medication belongs to a class of drugs known as nitrates. It works by relaxing and widening blood vessels so blood can flow more easily to the heart. This medication will not relieve chest pain once it occurs. Also, it is not intended to be taken just before physical activities (such as exercise or sexual intercourse) to prevent chest pain. Other medications may be prescribed by your doctor for these conditions. Consult your doctor for more details.
11-Digit NDC Billing Format:
68084043501
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
10 EA
Labeler Name:
American Health Packaging
Sample Package:
No
FDA Application Number:
ANDA076813
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
07-08-2013
End Marketing Date:
12-31-2014
Listing Expiration Date:
12-31-2014
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.

Frequently Asked Questions

What is NDC 68084-435-01?

The NDC Packaged Code 68084-435-01 is assigned to a package of 10 blister pack in 1 carton / 10 tablet, film coated, extended release in 1 blister pack (68084-435-11) of Isosorbide Mononitrate, labeled by American Health Packaging. The product's dosage form is and is administered via form.

Is NDC 68084-435 included in the NDC Directory?

The product was first marketed by American Health Packaging on July 08, 2013 and its listing in the NDC Directory is set to expire on December 31, 2014 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 68084-435-01?

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 10.

What is the 11-digit format for NDC 68084-435-01?

The 11-digit format is 68084043501. 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 5-3-2 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
5-3-268084-435-015-4-268084-0435-01