61958-0802 : Letairis 10 mg Oral Tablet

Labeler: Gilead Sciences, Inc
Product Type: Human Prescription Drug
Drug Name:  Letairis
Dosage Form: Oral Tablet, Film Coated
Application #: NDA022081
Rev. Date: 


Markings: GSI;10
Shapes:  Oval
Colors:  Red
Size (mm): 10
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:

  • 61958-0802-1: 30 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (61958‑0802‑1)
  • 61958-0802-2: 3 BLISTER PACK IN 1 CARTON (61958‑0802‑2) > 10 TABLET, FILM COATED IN 1 BLISTER PACK
  • 61958-0802-3: 1 BLISTER PACK IN 1 CARTON (61958‑0802‑3) > 10 TABLET, FILM COATED IN 1 BLISTER PACK
  • 61958-0802-5: 10 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (61958‑0802‑5)

Active Ingredients:

  • Ambrisentan

Dosage Strength:

  • 10 mg

Inactive Ingredients:

  • Croscarmellose Sodium
  • Lactose Monohydrate
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Fd&c Red No. 40
  • Aluminum Oxide
  • Lecithin, Soybean
  • Polyethylene Glycol 3350
  • Polyvinyl Alcohol
  • Talc
  • Titanium Dioxide

Pharmaceutical Classes:

  • Endothelin Receptor Antagonist [EPC]
  • Endothelin Receptor Antagonists [MoA]

Related Products:

Based on records with the same trade name.
  • 61958-0801 Letairis 5 mg Oral Tablet by Gilead Sciences, Inc


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