SPL Set ID: 2fc689b7-d5ba-4591-8c23-b48e588d7a28

Bromfenac ophthalmic solution, 0.09% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Each mL of bromfenac ophthalmic solution, 0.09% contains 1.035 mg bromfenac sodium (equivalent to 0.9 mg bromfenac free acid). Bromfenac sodium is designated chemically as sodium 2-amino-3-(4-bromobenzoyl) phenylacetate sesquihydrate, with a molecular formula of C 15 H 11 BrNNaO 3 . 1½ H 2 O. The structural structure for bromfenac sodium is: Bromfenac sodium is a yellow to orange crystalline powder. The molecular weight of bromfenac sodium is 383.17. Bromfenac ophthalmic solution is supplied as a sterile aqueous 0.09% solution, with a pH of 8.3. The osmolality of bromfenac ophthalmic solution is approximately 300 mOsmol/kg. Each mL of bromfenac ophthalmic solution contains: Active: bromfenac sodium hydrate 0.1035% (1.035 mg) Preservative: benzalkonium chloride NF (0.05 mg/mL) Inactives: boric acid, edetate disodium dihydrate (0.2 mg/mL), polysorbate 80 (1.5 mg/mL), povidone (20 mg/mL), sodium borate, sodium sulfite anhydrous (2 mg/mL), sodium hydroxide to adjust pH and water for injection. Molecular Structure