SPL Set ID: e8b50444-fd49-427e-9c1b-f75cb1b62bb6

1 drug(s) with this SPL Set ID

Open DailyMed details

LOTEPREDNOL ETABONATE LOTEPREDNOL ETABONATE
AMNEAL PHARMACEUTICALS NY LLC 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 crystalline powder. Loteprednol etabonate is represented by the following structural formula: Molecular formula: C 24 H 31 ClO 7 Molecular weight: 466.95 g/mol 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, Tyloxapol and Water for Injection. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 3.5 to 6.0. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium Chloride, 0.01%. 00

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