Ketorolac Tromethamine (Page 8 of 8)

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Ketorolac Tromethamine Tablets USP 10mg 30s Label Text

NDC 33261-0065 -30

KETOROLAC
TROMETHAMINE
Tablets USP
10 mg

PHARMACIST: Dispense the Medication
Guide provided separately to each patient.

Rx only

30 TABLETS

KETOROLAC TROMETHAMINE
ketorolac tromethamine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33261-065(NDC:0093-0314)
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
HYDROXYPROPYL CELLULOSE (TYPE H)
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 93;314
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33261-065-10 10 TABLET, FILM COATED (10 TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:33261-065-15 15 TABLET, FILM COATED (15 TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:33261-065-20 20 TABLET, FILM COATED (20 TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:33261-065-30 30 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074754 06/17/1998
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 01/2014 Aidarex Pharmaceuticals LLC

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