NDC 21695-575 Isosorbide Mononitrate

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
21695-575
Proprietary Name:
Isosorbide Mononitrate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Rebel Distributors Corp
Labeler Code:
21695
Start Marketing Date: [9]
10-30-1998
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
CAPSULE (C48336)
Size(s):
9 MM
Imprint(s):
KU;128;
Score:
2

Product Packages

NDC Code 21695-575-30

Package Description: 30 TABLET, EXTENDED RELEASE in 1 BOTTLE

NDC Code 21695-575-90

Package Description: 90 TABLET, EXTENDED RELEASE in 1 BOTTLE

Product Details

What is NDC 21695-575?

The NDC code 21695-575 is assigned by the FDA to the product Isosorbide Mononitrate which is product labeled by Rebel Distributors Corp. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 21695-575-30 30 tablet, extended release in 1 bottle , 21695-575-90 90 tablet, extended release in 1 bottle . 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 Isosorbide Mononitrate?

Isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition (coronary artery disease). This medication belongs to a class of drugs known as nitrates. It works by relaxing and widening blood vessels so blood can flow more easily to the heart. This medication will not relieve chest pain once it occurs. Also, it is not intended to be taken just before physical activities (such as exercise or sexual intercourse) to prevent chest pain. Other medications may be prescribed by your doctor for these conditions. Consult your doctor for more details.

Which are Isosorbide Mononitrate UNII Codes?

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

What is the NDC to RxNorm Crosswalk for Isosorbide Mononitrate?

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: 317110 - isosorbide mononitrate 30 MG 24HR Extended Release Oral Tablet
  • RxCUI: 317110 - 24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet
  • RxCUI: 317110 - isosorbide mononitrate 30 MG 24 HR Extended Release Oral Tablet

* Please review the disclaimer below.

Product Footnotes

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

[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".