Ketorolac Tromethamine (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69543-388-10

Ketorolac
Tromethamine
Tablets, USP

10 mg

PHARMACIST: Dispense the
accompanying Medication Guide to
each patient.

100 Tablets Rx Only

label-10-mg
(click image for full-size original)

KETOROLAC TROMETHAMINE ketorolac tromethamine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69543-388
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOROLAC TROMETHAMINE (KETOROLAC) KETOROLAC TROMETHAMINE 10 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
HYPROMELLOSE 2910 (3 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
SHELLAC
ISOPROPYL ALCOHOL
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
WATER
Product Characteristics
Color WHITE (White, film coated tablets) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 54;033
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69543-388-10 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210616 10/11/2018 09/30/2024
Labeler — Virtus Pharmaceuticals, LLC (079659493)
Registrant — Cycle Pharmaceuticals Ltd (218215530)

Revised: 05/2022 Virtus Pharmaceuticals, LLC

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