NDC Code(s) : 63187-777-05, 63187-777-10
Packager : Proficient Rx LP

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Ketorolac Tromethamineketorolac tromethamine SOLUTION/ DROPS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-777(NDC:60505-1003)
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)
OCTOXYNOL-40(UNII: 9T1C662FKS)
WATER(UNII: 059QF0KO0R)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63187-777-051 in 1 CARTON 11/01/2016
15 mL in 1 BOTTLE, DROPPER Type 0: Not a Combination Product
2NDC:63187-777-101 in 1 CARTON 11/01/2016
210 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
ANDA ANDA076109 12/07/2009

LABELER - Proficient Rx LP(079196022)

Establishment
Name Address ID/FEI Business Operations
Proficient Rx LP 079196022 RELABEL(63187-777)

PRINCIPAL DISPLAY PANEL

Representative sample of labeling (see the HOW SUPPLIED section for complete listing):

PRINCIPAL DISPLAY PANEL - 0.5% BOTTLE LABEL

APOTEX CORP. NDC 63187-777-05

KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION 0.5%

Rx only

5 ml

63187-777-05