NDC 67544-224 Isosorbide Mononitrate
View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Product Characteristics
Code Structure Chart
Product Details
What is NDC 67544-224?
What are the uses for Isosorbide Mononitrate?
Which are Isosorbide Mononitrate UNII Codes?
The UNII codes for the active ingredients in this product are:
- ISOSORBIDE MONONITRATE (UNII: LX1OH63030)
- ISOSORBIDE MONONITRATE (UNII: LX1OH63030) (Active Moiety)
What is the NDC to RxNorm Crosswalk for Isosorbide Mononitrate?
- RxCUI: 353538 - isosorbide mononitrate 60 MG 24HR Extended Release Oral Tablet
- RxCUI: 353538 - 24 HR isosorbide mononitrate 60 MG Extended Release Oral Tablet
- RxCUI: 353538 - isosorbide mononitrate 60 MG 24 HR Extended Release Oral Tablet
* Please review the disclaimer below.
Patient Education
Isosorbide
Isosorbide immediate-release tablets are used for the management of angina (chest pain) in people who have coronary artery disease (narrowing of the blood vessels that supply blood to the heart). Isosorbide extended-release (long-acting) tablets and extended-release capsules are used for the management of chest pain in people who have coronary artery disease. Isosorbide can only be used to prevent angina; it cannot be used to treat an episode of angina once it has begun. Isosorbide is in a class of medications called vasodilators. It works by relaxing the blood vessels so the heart does not need to work as hard and therefore does not need as much oxygen.
[Learn More]
* Please review the disclaimer below.
[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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".