SPL Set ID: 20cd29cc-cef5-48c4-adfe-6b3dfee0ab61

1 drug(s) with this SPL Set ID

Open DailyMed details

Zoledronic acid ZOLEDRONIC ACID
4 mg/5 ml Injection
MYLAN INSTITUTIONAL LLC FDA Rx Only

Zoledronic acid injection contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronicacid, USP is designated chemically as (1-Hydroxy-2-imidazol-1-yl-ethylidene) diphosphonic acid, monohydrate and its structural formula is: Zoledronic acid, USP is a white or practically white, crystalline powder. Its molecular formula is C5H10N2O7P2•H2O and its molar mass is 290.1 g/mol. 1 part of zoledronic acid, USP should dissolve in 35 parts of 0.1N sodium hydroxide solution and slightly soluble in water. The pH of a 0.25% solution of zoledronic acid, USP in water is approximately 2.0. Zoledronic acid injection is available in 5 mL vials as a sterile liquid solution for dilution prior to intravenous infusion. Each 5 mL solution for dilution prior to intravenous infusion vial contains 4.264 mg of zoledronic acid monohydrate, corresponding to 4 mg zoledronic acid, USP on an anhydrous basis, 220 mg of mannitol USP, water for injection, and 24 mg of sodium citrate, USP. Inactive Ingredients: mannitol, USP, as bulking agent, water for injection, and sodium citrate, USP, as buffering agent. structural formula

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