NDC Code(s) : 0023-9277-05
Packager : Allergan, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ACULAR LSKetorolac Tromethamine SOLUTION/ DROPS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0023-9277
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
EDETATE DISODIUM(UNII: 7FLD91C86K)
OCTOXYNOL-40(UNII: 9T1C662FKS)
WATER(UNII: 059QF0KO0R)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0023-9277-051 in 1 CARTON 19/08/2003
15 mL in 1 BOTTLE, DROPPER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021528 08/19/2003

LABELER - Allergan, Inc.(144796497)

PRINCIPAL DISPLAY PANEL

Principal Display Panel

ALLERGAN™ 

NDC 0023-9277-05

ACULAR LS™ 

(ketorolac tromethamine

ophthalmic solution) 0.4%

sterile Rx only 

5 mL

Principal Display Panel ALLERGAN™ NDC 0023-9277-05 ACULAR LS™ (ketorolac tromethamine ophthalmic solution) 0.4% sterile Rx only 5 mL