PRADAXA (Page 6 of 6)

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Pradaxa 150mg
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PRADAXA dabigatran etexilate mesylate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-899(NDC:0597-0135)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
dabigatran etexilate mesylate (dabigatran etexilate) dabigatran etexilate 150 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA
DIMETHICONE
HYPROMELLOSES
HYDROXYPROPYL CELLULOSE
TALC
TARTARIC ACID
CARRAGEENAN
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
POTASSIUM CHLORIDE
TITANIUM DIOXIDE
SHELLAC
ALCOHOL
METHYL ALCOHOL
BUTYL ALCOHOL
ISOPROPYL ALCOHOL
FERROSOFERRIC OXIDE
WATER
PROPYLENE GLYCOL
Product Characteristics
Color BLUE (Light Blue) , WHITE (Cream colored) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code R150;
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-899-60 60 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022512 10/26/2010
Labeler — Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 11/2010 Rebel Distributors Corp

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