Nitroglycerin Patch
NDC 0378-9104
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Nitroglycerin is a ANDA-approved product labeled by Mylan Pharmaceuticals Inc.. This medication is used to relieve chest pain (angina) in people that have a certain heart condition (coronary artery disease). It is supplied as a patch for transdermal administration. This product entry covers the primary NDC 0378-9104 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
0378-9104
Proprietary Name:
Nitroglycerin
Non-Proprietary Name: [1]
Nitroglycerin
Substance Name: [2]
Nitroglycerin
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Patch
- A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
Administration Route(s): [4]
Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
0378
Product Label ID:
FDA Application Number: [6]
ANDA074559
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
08-30-1996
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 0378-9104?
The NDC code 0378-9104 is assigned by the FDA to the product Nitroglycerin. This pharmaceutical product is labeled by Mylan Pharmaceuticals Inc. and is currently categorized as listed product. The medication is a patch administered via transdermal route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0378-9104-93. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
This medication is used to relieve chest pain (angina) in people that have a certain heart condition (coronary artery disease). It may also be used before physical activities (such as exercise, sexual activity) to help prevent chest pain. Nitroglycerin belongs to a class of drugs known as nitrates. Angina occurs when the heart muscle is not getting enough blood. This drug works by relaxing and widening blood vessels so blood can flow more easily to the heart.
What are Active Ingredients of this product?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
- NITROGLYCERIN .2 mg/h - A volatile vasodilator which relieves ANGINA PECTORIS by stimulating GUANYLATE CYCLASE and lowering cytosolic calcium. It is also sometimes used for TOCOLYSIS and explosives.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- NITROGLYCERIN (UNII: G59M7S0WS3)
- NITROGLYCERIN (UNII: G59M7S0WS3) (Active Moiety)
Which are the Inactive Ingredients associated UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
What is the NDC to RxNorm Crosswalk for this product?
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:
- RxCUI: 486146 - nitroglycerin 0.6 MG/HR 24HR Transdermal System
- RxCUI: 486146 - 24 HR nitroglycerin 0.6 MG/HR Transdermal System
- RxCUI: 486146 - 24 HR NTG 0.6 MG/HR Transdermal System
- RxCUI: 486146 - 24 HR TNG 0.6 MG/HR Transdermal System
- RxCUI: 486146 - nitroglycerin 14 MG/Day 24 HR Transdermal Patch
Which are the Pharmacologic Classes of this product?
A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.
* Please review the full disclaimer at the bottom of this page.
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.
[Learn More]
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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".
