NDC Code(s) : 41616-219-90, 41616-220-90, 41616-221-90
Packager : Sun Pharma Global Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Ketorolac Tromethamine Ketorolac Tromethamine SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:41616-219
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOROLAC TROMETHAMINE(UNII: 4EVE5946BQ)
(KETOROLAC - UNII:YZI5105V0L) 		KETOROLAC TROMETHAMINE5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM(UNII: 7FLD91C86K)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:41616-219-903 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090017 11/06/2009
Ketorolac Tromethamine Ketorolac Tromethamine SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:41616-220
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOROLAC TROMETHAMINE(UNII: 4EVE5946BQ)
(KETOROLAC - UNII:YZI5105V0L) 		KETOROLAC TROMETHAMINE5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM(UNII: 7FLD91C86K)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:41616-220-905 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090017 11/06/2009
Ketorolac Tromethamine Ketorolac Tromethamine SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:41616-221
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOROLAC TROMETHAMINE(UNII: 4EVE5946BQ)
(KETOROLAC - UNII:YZI5105V0L) 		KETOROLAC TROMETHAMINE5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM(UNII: 7FLD91C86K)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:41616-221-9010 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090017 11/06/2009

PRINCIPAL DISPLAY PANEL

NDC 41616-219-90
Ketorolac Tromethamine Ophthalmic Solution
0.5%
Rx only
3 mL

ketorolac-label-3ml

PRINCIPAL DISPLAY PANEL

NDC 41616-219-90
Ketorolac Tromethamine Ophthalmic Solution
0.5%
FOR USE IN THE EYES ONLY
3 mL
Rx only
SUN PHARMACEUTICAL INDUSTRIES LTD.

ketorolac-carton-3ml


PRINCIPAL DISPLAY PANEL

NDC 41616-220-90
Ketorolac Tromethamine Ophthalmic Solution
0.5%
Rx only
5 mL

ketorolac-label-5ml

PRINCIPAL DISPLAY PANEL

NDC 41616-220-90
Ketorolac Tromethamine Ophthalmic Solution
0.5%
FOR USE IN THE EYES ONLY
5 mL
Rx only
SUN PHARMACEUTICAL INDUSTRIES LTD.

ketorolac-carton-5ml


PRINCIPAL DISPLAY PANEL

NDC 41616-221-90
Ketorolac Tromethamine Ophthalmic Solution
0.5%
Rx only
10 mL

ketorolac-label-10ml

PRINCIPAL DISPLAY PANEL

NDC 41616-221-90
Ketorolac Tromethamine Ophthalmic Solution
0.5%
FOR USE IN THE EYES ONLY
10 mL
Rx only
SUN PHARMACEUTICAL INDUSTRIES LTD.

ketorolac-carton-10ml