NDC Code(s) : 52125-739-08
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

OfloxacinOfloxacin SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-739(NDC:24208-410)
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OFLOXACIN(UNII: A4P49JAZ9H)
(OFLOXACIN - UNII:A4P49JAZ9H) 		OFLOXACIN3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-739-0810 mL in 1 BOTTLE, DROPPER Type 0: Not a Combination Product04/09/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076128 09/04/2014 01/20/2016

PRINCIPAL DISPLAY PANEL

DRUG: Ofloxacin


GENERIC: Ofloxacin


DOSAGE: SOLUTION


ADMINSTRATION: AURICULAR (OTIC)


NDC: 52125-739-08


ACTIVE INGREDIENT(S):

  • OFLOXACIN 3mg in 1mL


INACTIVE INGREDIENT(S):

  • BENZALKONIUM CHLORIDE
  • SODIUM CHLORIDE
  • SODIUM HYDROXIDE
  • HYDROCHLORIC ACID
  • WATER


PACKAGING: 10 mL in 1 BOTTLE, DROPPER




/xml/006095a1-0ac2-4142-9527-f3b058c1d7bc/MM8.jpg

/xml/006095a1-0ac2-4142-9527-f3b058c1d7bc/MM8.jpg