ents: colloidal silicon dioxide, croscarmellose sodium, D&C Red No. 40, dibasic calcium phosphate (anhydrous), FD&C Blue No. 2, hypromellose acetate succinate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, sodium stearyl fumarate, talc, and titanium dioxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured for
Vertex Pharmaceuticals Incorporated
Cambridge, MA 02139
Issued May 2011
©2011 Vertex Pharmaceuticals Incorporated
All rights reserved.
INCIVEK and the Blue Arrow logo are trademarks of Vertex Pharmaceuticals Incorporated. VERTEX and the VERTEX triangle logo are registered trademarks of Vertex Pharmaceuticals Incorporated.
The brands listed are trademarks of their respective owners. They are not trademarks of Vertex Pharmaceuticals Incorporated. The makers of these brands are not affiliated with and do not endorse Vertex Pharmaceuticals Incorporated or its products.
PRINCIPAL DISPLAY PANEL - 375 mg Tablet Carton
168 TABLETS
NDC 51167-100-01
INCIVEK™
(telaprevir)
Tablets
375 mg
Rx only
ATTENTION PHARMACIST: Dispense the enclosed Medication Guide to each patient.
INCIVEK
telaprevir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51167-100
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
telaprevir (telaprevir) telaprevir 375mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
SODIUM STEARYL FUMARATE
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)
SODIUM LAURYL SULFATE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3350
TALC
FD&C Blue No. 2
FD&C Red No. 40
Product Characteristics
Color PURPLE Score no score
Shape OVAL Size 20mm
Flavor Imprint Code V;375
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51167-100-01 4 BOX ( BOX) in 1 CARTON contains a BOX
1 7 BLISTER PACK ( BLISTER PACK) in 1 BOX This package is contained within the CARTON(51167-100-01) andcontains a BLISTER PACK
1 6 TABLET, FILM COATED ( TABLET) in 1 BLISTER PACK This package is contained within a BOX and a CARTON(51167-100-01)
2 NDC:51167-100-02 168 TABLET, FILM COATED ( TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201917 05/23/2011
Labeler -Vertex Pharmaceuticals Incorporated (602478257)
Establishment
Name Address ID/FEI Operations
Vertex Pharmaceuticals Incorporated 602478257 MANUFACTURE
