51167-100 : Incivek 375 mg Oral Tablet

Labeler: Vertex Pharmaceuticals Incorporated
Product Type: Human Prescription Drug
Drug Name:  Incivek
Dosage Form: Oral Tablet, Film Coated
Application #: NDA201917
Rev. Date: 


Markings: V;375
Shapes:  Oval
Colors:  Purple
Size (mm): 20
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 51167-100-01: 4 BOX IN 1 CARTON (51167‑100‑01) > 7 BLISTER PACK IN 1 BOX > 6 TABLET, FILM COATED IN 1 BLISTER PACK
  • 51167-100-03: 4 BOX IN 1 CARTON (51167‑100‑03) > 7 BLISTER PACK IN 1 BOX > 6 TABLET, FILM COATED IN 1 BLISTER PACK

Active Ingredients:

  • Telaprevir

Dosage Strength:

  • 375 mg

Inactive Ingredients:

  • Calcium Phosphate, Dibasic, Anhydrous
  • 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

Pharmaceutical Classes:

  • HCV NS3/4A Protease Inhibitors [MoA]
  • Hepatitis C Virus NS3/4A Protease Inhibitor [EPC]


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