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  4. NDC Product Code: 50090-1963 Isosorbide Mononitrate

NDC 50090-1963 Isosorbide Mononitrate

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 50090-1963?
  5. Isosorbide Mononitrate Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 50090-1963 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:
50090-1963
Proprietary Name:
Isosorbide Mononitrate
Product Type: [3]
Labeler Name: [5]
A-s Medication Solutions
Labeler Code:
50090
Product Label ID:
b14cd7e5-48ea-4f24-ac01-1635f43f3e03
FDA Application Number: [6]
ANDA090598
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
08-11-2010
End Marketing Date: [10]
10-18-2016
Listing Expiration Date: [11]
10-18-2016
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - OFF WHITE)
Shape:
OVAL (C48345)
Size(s):
15 MM
Imprint(s):
3798;V
Score:
2

Code Structure Chart

Product Details

What is NDC 50090-1963?

The NDC code 50090-1963 is assigned by the FDA to the product Isosorbide Mononitrate which is product labeled by A-s Medication Solutions. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 50090-1963-0 30 tablet, extended release in 1 bottle , 50090-1963-1 100 tablet, extended release in 1 bottle , 50090-1963-2 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:

  • ISOSORBIDE MONONITRATE (UNII: LX1OH63030)
  • ISOSORBIDE MONONITRATE (UNII: LX1OH63030) (Active Moiety)

Which are Isosorbide Mononitrate Inactive Ingredients 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:

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
  • RxCUI: 353538 - isosorbide mononitrate 60 MG 24HR Extended Release Oral Tablet
  • RxCUI: 353538 - 24 HR isosorbide mononitrate 60 MG 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.

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.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[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".