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  4. NDC Product Code: 68382-310 Nitroglycerin Transdermal System

NDC 68382-310 Nitroglycerin Transdermal System

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 68382-310?
  4. Nitroglycerin Transdermal System Uses
  5. Active Ingredients UNII Codes
  6. NDC to RxNorm Crosswalk
  7. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Get all the details for National Drug Code (NDC) 68382-310 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
68382-310
Proprietary Name:
Nitroglycerin Transdermal System
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Zydus Pharmaceuticals Usa Inc.
Labeler Code:
68382
Product Label ID:
e3da9f52-d094-49d2-90d8-994bd839a4a7
FDA Application Number: [6]
ANDA089885
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
02-15-2017
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
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Product Details

What is NDC 68382-310?

The NDC code 68382-310 is assigned by the FDA to the product Nitroglycerin Transdermal System which is product labeled by Zydus Pharmaceuticals Usa Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 68382-310-30 30 pouch in 1 carton / 1 patch in 1 pouch (68382-310-01) / 14 h in 1 patch. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Nitroglycerin Transdermal System?

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.

Which are Nitroglycerin Transdermal System UNII Codes?

The UNII codes for the active ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Nitroglycerin Transdermal System?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Patient Education

Nitroglycerin Transdermal Patch


Nitroglycerin transdermal patches are used to prevent episodes of angina (chest pain) in people who have coronary artery disease (narrowing of the blood vessels that supply blood to the heart). Nitroglycerin transdermal patches can only be used to prevent attacks of angina; they cannot be used to treat an attack of angina once it has begun. Nitroglycerin is in a class of medications called vasodilators. It works by relaxing the blood vessels so that the heart does not need to work as hard and therefore does not need as much oxygen.
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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".