51167-113 : SymdekoSymdeko Kit


NDC: 51167-113
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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NDC 51167-113 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.