NDC Code(s) : 61314-018-05
Packager : Sandoz Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

KETOROLAC TROMETHAMINEketorolac tromethamine SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61314-018
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOROLAC TROMETHAMINE(UNII: 4EVE5946BQ)
(KETOROLAC - UNII:YZI5105V0L) 		KETOROLAC TROMETHAMINE4 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)
EDETATE DISODIUM(UNII: 7FLD91C86K)
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
OCTOXYNOL-40(UNII: 9T1C662FKS)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61314-018-055 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078721 11/05/2009

PRINCIPAL DISPLAY PANEL

NDC 61314-018-05

Ketorolac Tromethamine Ophthalmic Solution, 0.4 %

FOR TOPICAL OPHTHALMIC USE ONLY

Rx only

Sterile

5 mL

5 mL carton