OFLOXACIN (Page 3 of 3)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

931
(click image for full-size original)

OFLOXACIN ofloxacin solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-931(NDC:61314-015)
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
SODIUM CHLORIDE
WATER
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61919-931-05 5 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078222 01/01/2014
Labeler — DIRECT RX (079254320)
Establishment
Name Address ID/FEI Operations
DIRECT RX 079254320 relabel (61919-931), repack (61919-931)

Revised: 01/2020 DIRECT RX

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