ISORDIL TITRADOSE Tablet Ref.[27504] Active ingredients: Isosorbide dinitrate

Source: FDA, National Drug Code (US)  Revision Year: 2019 

Product description

Isosorbide dinitrate (ISDN) is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate, an organic nitrate whose structural formula is

and whose molecular weight is 236.14. The organic nitrates are vasodilators, active on both arteries and veins.

Isosorbide dinitrate is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of 70°C and has an optical rotation of +134° (c=1.0, alcohol, 20°C). Isosorbide dinitrate is freely soluble in organic solvents such as acetone, alcohol, and ether, but is only sparingly soluble in water.

Each Isordil Titradose tablet contains 5 mg or 40 mg of isosorbide dinitrate. The inactive ingredients in 5 mg tablet are magnesium stearate, lactose monohydrate, microcrystalline cellulose and FD&C red 40. The inactive ingredients in 40 mg tablet are magnesium stearate, microcrystalline cellulose, FD&C yellow 6, D&C yellow 10, and FD&C blue.

How Supplied

IsordilTitradose (isosorbide dinitrate) tablets are available as follows:

5 mg, round, pink tablets imprinted “BPI 152” on one side and deeply scored on reverse side:

NDC 0187-0152-01, bottles of 100.

40 mg, round, light green tablets imprinted “BPI 192” on one side and deeply scored on reverse side:

NDC 0187-0192-01, bottles of 100.

Manufactured for: Bausch Health US, LLC, Bridgewater, NJ 08807 USA

Manufactured by: Bausch Health Companies Inc., Steinbach, MB R5G 1Z7, Canada

Drugs

Drug Countries
ISORDIL Australia, Brazil, Netherlands, Turkey, United States, South Africa

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