SPL Set ID: bf1afcd5-e1da-4874-981f-f252cb0b32c2

1 drug(s) with this SPL Set ID

Open DailyMed details

Etodolac ETODOLAC
400 mg
EDENBRIDGE PHARMACEUTICALS LLC. FDA Rx Only

Etodolac Tablets USP are members of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol: water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C 17 H 21 NO 3 , and it has the following structural formula: Each tablet, for oral administration, contains 400 mg or 500 mg of etodolac. In addition, each tablet contains the following inactive ingredients : Hydroxypropyl Methylcellulose USP, Lactose Monohydrate NF, Magnesium Stearate, Microcrystalline Cellulose NF, Polyethylene Glycol, Povidone USP, Sodium Starch Glycolate NF and Titanium Dioxide. Also, each 400 mg tablet contains Iron Oxide Yellow and Iron Oxide Red. Each 500 mg tablet contains FD&C Indigo Carmine Aluminum Lake, Polysorbate 80 and Iron Oxide Red. image

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