Source: FDA, National Drug Code (US) Revision Year: 2017
OCUFLOX (ofloxacin ophthalmic solution) 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use.
Chemical Name:
(±)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7Hpyrido[1,2,3de]-1,4-benzoxazine-6-carboxylic acid.
Contains:
Active: ofloxacin 0.3% (3 mg/mL).
Preservative: benzalkonium chloride (0.005%).
Inactives: sodium chloride and purified water. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.
OCUFLOX solution is unbuffered and formulated with a pH of 6.4 (range – 6.0 to 6.8). It has an osmolality of 300 mOsm/kg. Ofloxacin is a fluorinated 4-quinolone which differs from other fluorinated 4-quinolones in that there is a six member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure.
| How Supplied |
|---|
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OCUFLOX (ofloxacin ophthalmic solution) 0.3% is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with tan high impact polystyrene (HIPS) caps as follows: 5mL in 10mL bottle – NDC 11980-779-05 Irvine, CA 92612, U.S.A. |
| Drug | Countries | |
|---|---|---|
| OCUFLOX | Australia, Canada, Mexico, United States |
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