Source: FDA, National Drug Code (US) Revision Year: 2019
ALREX (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:
Chemical Name:
chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate
Each mL contains:
ACTIVE: Loteprednol Etabonate 2 mg (0.2%);
INACTIVES: Edetate Disodium, Glycerin, Povidone, Purified Water and Tyloxapol. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg.
PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.
| How Supplied |
|---|
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ALREX (loteprednol etabonate ophthalmic suspension, 0.2%) is supplied in a plastic bottle with a controlled drop tip in the following sizes: NDC 24208-353-05 5 mL in a 7.5 mL bottle Distributed by: Bausch + Lomb, a division of Bausch Health US, LLC, Bridgewater, NJ 08807 USA Manufactured by: Bausch and & Lomb Incorporated, Tampa, FL 33637 USA |
| Drug | Countries | |
|---|---|---|
| ALREX | Brazil, Canada, Hong Kong, Singapore, United States, South Africa |
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