NDC Code(s) : 42571-137-31, 42571-137-25, 42571-137-26
Packager : Micro Labs Limited

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:42571-137
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
SODIUM CHLORIDE(UNII: 451W47IQ8X)
EDETATE DISODIUM(UNII: 7FLD91C86K)
OCTOXYNOL-40(UNII: 9T1C662FKS)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42571-137-313 mL in 1 BOTTLE Type 0: Not a Combination Product06/03/2019
2NDC:42571-137-255 mL in 1 BOTTLE Type 0: Not a Combination Product06/03/2019
3NDC:42571-137-2610 mL in 1 BOTTLE Type 0: Not a Combination Product06/03/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203410 06/03/2019

LABELER - Micro Labs Limited(862174955)

Establishment
Name Address ID/FEI Business Operations
Micro Labs Limited 677600482 analysis(42571-137), label(42571-137), manufacture(42571-137), pack(42571-137)

PRINCIPAL DISPLAY PANEL

NDC 42571-137-31
Ketorolac Tromethamine Ophthalmic Solution
0.5%
3 mL
FOR USE IN EYES ONLY

ketorolactromethamine-lbl.jpg

ketorolactromethamine-lbl.jpg