Source: FDA, National Drug Code (US) Revision Year: 2023
Omlonti (omidenepag isopropyl ophthalmic solution) 0.002%, contains the prodrug form of the active omidenepag, a relatively selective prostaglandin EP2 receptor agonist with ocular hypotensive activity. Omidenepag isopropyl is a white to light brown crystal or crystalline powder and practically insoluble in water. Omidenepag isopropyl’s chemical name is Glycine, N-[6-[[[[4-(1H-pyrazol-1-yl)phenyl]methyl](3-pyridinylsulfonyl)amino]methyl]-2-pyridinyl]-, 1-methylethyl ester and has the following structure:
Structural Formula:
Formula of the free base: C26H28N6O4S.
Molecular weight: 520.61
Omlonti appears as a clear, colorless solution. It is supplied as a sterile, isotonic, buffered aqueous solution of omidenepag isopropyl with a target pH of 5.8 and an osmolality of approximately 285 mOsmol/kg.
Each mL of Omlonti contains:
Active: 0.02 mg of omidenepag isopropyl.
Preservative: 0.005% benzalkonium chloride.
Inactive ingredients: glycerin, polyoxyl 35 castor oil, sodium citrate, citric acid monohydrate, edetate disodium, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection.
| Dosage Forms and Strengths |
|---|
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Omidenepag isopropyl ophthalmic solution: 0.002% (0.02 mg/mL). |
| How Supplied |
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Omlonti (omidenepag isopropyl ophthalmic solution) 0.002%, is supplied as a 2.5 mL sterile solution in 5 mL white low density polyethylene bottles with linear low density polyethylene dropper tips, high density polyethylene screw caps and tamper-evident low density polyethylene overcaps. NDC 65086-002-05 Manufactured for: Santen Inc. Manufactured by: Woodstock Sterile Solutions, Inc. Distributed by: Santen Inc., 6401 Hollis Street, Suite 125, Emeryville, CA 94608, United States |
| Drug | Countries | |
|---|---|---|
| OMLONTI | United States |
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