SPL Set ID: c23fb7fe-c6b9-4f77-bde7-992222b589d3

1 drug(s) with this SPL Set ID

Open DailyMed details

Alendronate Sodium ALENDRONATE SODIUM
AMNEAL PHARMACEUTICALS OF NEW YORK LLC FDA Rx Only

Alendronate Sodium Tablets, USP is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium, USP is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The structural formula is: C 4 H 12 NNaO 7 P 2 •3H 2 O M.W. 325.12 Alendronate sodium, USP is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Each tablet for oral administration contains 6.53, 13.05, 45.68, 52.21 or 91.36 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. Alendronate Sodium Tablets, USP meet USP Dissolution Test 2. image of alendronate sodium chemical structure

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