NDC Code(s) : 58118-9825-1
Packager : Clinical Solutions Wholesale

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CIPRODEXciprofloxacin and dexamethasone SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-9825(NDC:0065-8533)
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CIPROFLOXACIN HYDROCHLORIDE(UNII: 4BA73M5E37)
(CIPROFLOXACIN - UNII:5E8K9I0O4U) 		CIPROFLOXACIN3 mg in 1 mL
DEXAMETHASONE(UNII: 7S5I7G3JQL)
(DEXAMETHASONE - UNII:7S5I7G3JQL) 		DEXAMETHASONE1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
BORIC ACID(UNII: R57ZHV85D4)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
TYLOXAPOL(UNII: Y27PUL9H56)
ACETIC ACID(UNII: Q40Q9N063P)
SODIUM ACETATE(UNII: 4550K0SC9B)
EDETATE DISODIUM(UNII: 7FLD91C86K)
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58118-9825-17.5 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021537 08/15/2003

PRINCIPAL DISPLAY PANEL

Ciprodex