Ofloxacin (Page 4 of 4)

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NDC 33261-0737-01

Ofloxacin
Otic Solution,
0.3% (Sterile)

Rx only

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USE IN EARS ONLY 5 mL

OFLOXACIN ofloxacin solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33261-737(NDC:24208-410)
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OFLOXACIN (OFLOXACIN) OFLOXACIN 3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE 0.2 mg in 1 mL
HYDROCHLORIC ACID
WATER
SODIUM CHLORIDE
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33261-737-01 1 BOTTLE, DROPPER (1 BOTTLE) in 1 CARTON contains a BOTTLE, DROPPER
1 5 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (33261-737-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076128 03/17/2008
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 01/2014 Aidarex Pharmaceuticals LLC

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