51167-113 : SymdekoSymdeko Kit


NDC51167-113
Labeler: Vertex Pharmaceuticals Incorporated
Product Type: Human Prescription Drug
Drug Name:  Symdeko
Dosage Form: Kit
Application #: NDA210491
Rev. Date: 


Appearance:


Markings: V;75
V50
Shapes:  Capsule
Colors:  White
Blue
Size (mm): 13
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:

  • 51167-113-01: 1 KIT IN 1 CARTON (51167‑113‑01) * 7 TABLET, FILM COATED IN 1 BLISTER PACK * 7 TABLET, FILM COATED IN 1 BLISTER PACK

Active Ingredients:

  • Ivacaftor

Kit Contents:

  • Ivacaftor
  • Tezacaftor and Ivacaftor

Inactive Ingredients:

  • Hypromellose Acetate Succinate 06081224 (3 Mm2/S)
  • Sodium Lauryl Sulfate
  • Hypromellose, Unspecified
  • Microcrystalline Cellulose
  • Croscarmellose Sodium
  • Magnesium Stearate
  • Hydroxypropyl Cellulose, Unspecified
  • Titanium Dioxide
  • Talc
  • Hypromellose 2910 (6 Mpa.s) /
  • Silicon Dioxide
  • Croscarmellose Sodium
  • Hypromellose Acetate Succinate 06081224 (3 Mm2/S)
  • Lactose Monohydrate
  • Magnesium Stearate
  • Microcrystalline Cellulose
  • Sodium Lauryl Sulfate
  • Carnauba Wax
  • Fd&c Blue No. 2
  • Polyethylene Glycol 3350
  • Polyvinyl Alcohol, Unspecified
  • Talc
  • Titanium Dioxide
  • Ammonia
  • Ferrosoferric Oxide
  • Propylene Glycol
  • Shellac /

Related Products:

Based on records with the same trade name.
  • 51167-661 Symdeko Kit by Vertex Pharmaceuticals Incorporated

NDC QR Code

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