Nitroglycerin Transdermal System
NDC Package 68382-310-30

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.

Nitroglycerin Transdermal System is transdermal nitroglycerin is indicated for the prevention of angina pectoris due to coronary artery disease. Marketed by Zydus Pharmaceuticals Usa Inc., this product is identified by NDC 68382-310 and is authorized under FDA application ANDA089885.

Identification & Billing

NDC Package Code
68382-310-30
Package Description
30 POUCH in 1 CARTON / 1 PATCH in 1 POUCH (68382-310-01) / 14 h in 1 PATCH
Product Code
68382-310
11-Digit Billing Format
68382031030
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nitroglycerin Transdermal System
Dosage Form
-
Usage Information
Transdermal nitroglycerin is indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of transdermal nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute attack.

Regulatory & Marketing

Labeler Name
Zydus Pharmaceuticals Usa Inc.
FDA Application #
ANDA089885
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-15-2017
Listing Expiration
12-31-2023
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 68382-310-30 identifies a specific commercial package of 30 pouch in 1 carton / 1 patch in 1 pouch (68382-310-01) / 14 h in 1 patch of Nitroglycerin Transdermal System, labeled by Zydus Pharmaceuticals Usa Inc.. 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 Zydus Pharmaceuticals Usa Inc. on February 15, 2017. The current certification is valid through December 31, 2023.

How is this Zydus Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68382031030. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
68382-310-30
11-Digit CMS (5-4-2)
68382-0310-30

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