01 1DOTTIKON EXCLUSIVE SYNTHESIS AG
02 2Dipharma Francis Srl
01 1ISOSORBIDE DINITRATE, DILUTED
02 2Isosorbide Dinitrate
01 2Italy
02 1Switzerland
NDC Package Code : 46438-0001
Start Marketing Date : 2005-08-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 46438-0634
Start Marketing Date : 2013-08-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 54864-106
Start Marketing Date : 1983-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
A Isosorbide Dinitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isosorbide Dinitrate, including repackagers and relabelers. The FDA regulates Isosorbide Dinitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isosorbide Dinitrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Isosorbide Dinitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Isosorbide Dinitrate supplier is an individual or a company that provides Isosorbide Dinitrate active pharmaceutical ingredient (API) or Isosorbide Dinitrate finished formulations upon request. The Isosorbide Dinitrate suppliers may include Isosorbide Dinitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Isosorbide Dinitrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Isosorbide Dinitrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Isosorbide Dinitrate API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Isosorbide Dinitrate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Isosorbide Dinitrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Isosorbide Dinitrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Isosorbide Dinitrate suppliers with NDC on PharmaCompass.
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