70183-125 : Xermelo 250 mg Oral Tablet

Labeler: Lexicon Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Xermelo
Dosage Form: Oral Tablet
Application #: NDA208794
Rev. Date: 


Markings: T;E;250
Shapes:  Oval
Colors:  White
Size (mm): 17
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:

  • 70183-125-84: 4 BOX IN 1 CASE (70183‑125‑84) > 7 BLISTER PACK IN 1 BOX (70183‑125‑21) > 3 TABLET IN 1 BLISTER PACK (70183‑125‑03)

Active Ingredients:

  • Telotristat Ethyl

Dosage Strength:

  • 250 mg

Inactive Ingredients:

  • Anhydrous Lactose
  • Hydroxypropyl Cellulose (120000 Mw)
  • Croscarmellose Sodium
  • Magnesium Stearate
  • Silicon Dioxide
  • Polyvinyl Alcohol, Unspecified
  • Titanium Dioxide
  • Polyethylene Glycols
  • Talc

Pharmaceutical Classes:

  • Tryptophan Hydroxylase Inhibitor [EPC]
  • Tryptophan Hydroxylase Inhibitors [MoA]


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