SPL Set ID: 8b48d2b3-61b5-4cfc-a8a0-7ccc235dfe5a

1 drug(s) with this SPL Set ID

Open DailyMed details

Indomethacin INDOMETHACIN
AMNEAL PHARMACEUTICALS NY LLC FDA Rx Only

Indomethacin suppositories, USP are a nonsteroidal anti-inflammatory drug, available as a suppository containing 50 mg of indomethacin, USP administered for rectal use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1 H -indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C 19 H 16 ClNO 4 , and it has the following chemical structure. Indomethacin, USP is a pale yellow to yellow-tan crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol, in chloroform and in ether. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in indomethacin suppositories, USP include: butylated hydroxyanisole, butylated hydroxytoluene, edetic acid, glycerin, polyethylene glycol 3350, polyethylene glycol 8000, purified water and sodium chloride. Indomethacin suppositories, USP 50 mg each, are yellow to white, opaque, rectal suppositories. FDA approved drug product storage condition and dissolution specifications differs from the USP. Structural Formula

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