SPL Set ID: 36cfd5b8-c892-44e1-aaed-fb32d7aeca7c

1 drug(s) with this SPL Set ID

Open DailyMed details

Loteprednol Etabonate LOTEPREDNOL ETABONATE
SUN PHARMACEUTICAL INDUSTRIES, INC. FDA Rx Only

Loteprednol etabonate ophthalmic suspension contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula: C 24 H 31 ClO 7 Mol. Wt. 466.96 Chemical Name: Chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate Each mL contains ACTIVE: Loteprednol Etabonate 5 mg (0.5%); INACTIVES: Edetate Disodium, Glycerin, Povidone, Water for Injection and Tyloxapol. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.0 - 6.0. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium Chloride Solution (50%) 0.2 mg. spl-loteprednol-structure

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