Source: FDA, National Drug Code (US) Revision Year: 2023
Quinidine is an antimalarial schizonticide and an antiarrhythmic agent with class 1A activity; it is the d-isomer of quinine, and its molecular weight is 324.43. Quinidine sulfate is the sulfate salt of quinidine; its chemical name is cinchonan-9-ol, 6'methoxy, (9S)-, sulfate (2:1) dihydrate; its structural formula is:
Its molecular formula is: C40H48N4O4∙H2SO4∙2H2O; and its molecular weight is 782.96, of which 82.9% is quinidine base.
Quinidine sulfate occurs as fine needle-like, white crystals, frequently cohering in masses, or fine, white powder. It is odorless, has a very bitter taste, and darkens on exposure to light. It is slightly soluble in water, soluble in alcohol and in chloroform, and insoluble in ether.
Each tablet, for oral administration, contains 200 mg of quinidine sulfate (equivalent to 166 mg of quinidine base) 300 mg of quinidine sulfate (equivalent to 249 mg of quinidine base). In addition, each tablet contains the following inactive ingredients: confectioner’s sugar, corn starch, microcrystalline cellulose, pregelatinized starch and zinc stearate.
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Quinidine Sulfate Tablets are supplied as follows: 200 mg – White tablet scored imprinted E511 NDC 42806-513-30 bottles of 30 300 mg – White tablet scored imprinted E512 NDC 42806-512-30 bottles of 30 Distributed by: Epic Pharma, LLC, Laurelton, NY 11413 |
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