Source: FDA, National Drug Code (US) Revision Year: 2020
ILEVRO 0.3% is a sterile, topical, NSAID prodrug for ophthalmic use. Each mL of ILEVRO 0.3% contains 3 mg of nepafenac. Nepafenac is designated chemically as 2-amino-3-benzoylbenzeneacetamide with an empirical formula of C15H14N2O2.
The structural formula of nepafenac is:
Nepafenac is a yellow crystalline powder. The molecular weight of nepafenac is 254.28 g/mol. ILEVRO 0.3% is supplied as a sterile, aqueous suspension with a pH approximately of 6.8.
The osmolality of ILEVRO 0.3% is approximately 300 mOsm/kg.
Each mL of ILEVRO 0.3% contains:
Active: nepafenac 0.3%.
Inactives: boric acid, propylene glycol, carbomer 974P, sodium chloride, guar gum, carboxymethylcellulose sodium, edetate disodium, benzalkonium chloride 0.005% (preservative), sodium hydroxide and/or hydrochloric acid to adjust pH and purified water, USP.
| Dosage Forms and Strengths |
|---|
|
Sterile ophthalmic suspension 0.3%: 1.7 mL in a 4 mL bottle and 3 mL in a 4 mL bottle. |
| How Supplied |
|---|
|
ILEVRO 0.3% is supplied in a white, oval, low density polyethylene DROP-TAINER dispenser with a natural low density polyethylene dispensing plug and gray polypropylene cap. The 1.7 mL fill is presented in an overwrap, which provides tamper evidence to the package. Tamper evidence for the 3 mL fill is provided with a shrink band around the closure and neck area of the package. 1.7 mL in 4 mL bottle NDC 0065-1750-07 Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134 USA |
| Drug | Countries | |
|---|---|---|
| ILEVRO | Canada, Ecuador, New Zealand, United States, South Africa |
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