Nitroglycerin
NDC 62175-124
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
Nitroglycerin is a ANDA-approved product labeled by Kremers Urban 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 product. This product entry covers the primary NDC 62175-124 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
62175-124
Proprietary Name:
Nitroglycerin
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
62175
Product Label ID:
FDA Application Number: [6]
ANDA075115
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
08-10-2004
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure Chart
Product Details
What is NDC 62175-124?
The NDC code 62175-124 is assigned by the FDA to the product Nitroglycerin. This pharmaceutical product is labeled by Kremers Urban Pharmaceuticals Inc. and is currently categorized as listed product. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 62175-124-01, 62175-124-11, 62175-124-31. 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.
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)
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: 486148 - nitroglycerin 0.2 MG/HR 24HR Transdermal System
- RxCUI: 486148 - 24 HR nitroglycerin 0.2 MG/HR Transdermal System
- RxCUI: 486148 - 24 HR NTG 0.2 MG/HR Transdermal System
- RxCUI: 486148 - 24 HR TNG 0.2 MG/HR Transdermal System
- RxCUI: 486148 - nitroglycerin 5 MG/Day 24 HR Transdermal Patch
* 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 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".
