Ketorolac Tromethamine (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

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KETOROLAC TROMETHAMINE ketorolac tromethamine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76420-184(NDC:0409-3796)
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOROLAC TROMETHAMINE (KETOROLAC) KETOROLAC TROMETHAMINE 60 mg in 2 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
WATER
SODIUM CHLORIDE 8.7 mg in 2 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76420-184-02 2 mL in 1 VIAL, SINGLE-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074802 10/30/2015
Labeler — Asclemed USA, Inc. (059888437)
Establishment
Name Address ID/FEI Operations
ASCLEMED USA INC. DBA ENOVACHEM 059888437 relabel (76420-184)

Revised: 11/2020 Asclemed USA, Inc.

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