Ketoprofen (Page 7 of 7)

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SPL Label

KETOPROFEN
ketoprofen capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53217-221(NDC:0093-3193)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOPROFEN (KETOPROFEN) KETOPROFEN 50 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
GELATIN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
D&C RED NO. 28
FD&C BLUE NO. 1
Product Characteristics
Color BLUE, BLUE (light blue) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 93;3193;93;3193
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53217-221-30 30 CAPSULE in 1 BOTTLE None
2 NDC:53217-221-45 45 CAPSULE in 1 BOTTLE None
3 NDC:53217-221-60 60 CAPSULE in 1 BOTTLE None
4 NDC:53217-221-90 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA073516 01/01/1993
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 11/2016 Aidarex Pharmaceuticals LLC

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