66215-103 : Tracleer 32 mg Oral Tablet, Soluble


NDC66215-103
Labeler: Actelion Pharmaceuticals Us, Inc.
Product Type: Human Prescription Drug
Drug Name:  Tracleer
Dosage Form: Oral Tablet, Soluble
Application #: NDA209279
Rev. Date: 


Appearance:


Markings: 32
Shapes:  Clover
Colors:  Yellow
Size (mm): 10
Segments: * 4

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 4 indicates a scored pill which can be broken into 4 equal pieces.

NDC Package Codes:

  • 66215-103-14: 4 BLISTER PACK IN 1 CARTON (66215‑103‑14) > 14 TABLET, SOLUBLE IN 1 BLISTER PACK
  • 66215-103-56: 4 BLISTER PACK IN 1 CARTON (66215‑103‑56) > 14 TABLET, SOLUBLE IN 1 BLISTER PACK (66215‑103‑14)

Active Ingredients:

  • Bosentan

Dosage Strength:

  • 32 mg

Inactive Ingredients:

  • Microcrystalline Cellulose
  • Anhydrous Dibasic Calcium Phosphate
  • Croscarmellose Sodium
  • Silicon Dioxide
  • Tartaric Acid
  • Aspartame
  • Acesulfame Potassium
  • Magnesium Stearate
  • Phenylalanine

Pharmaceutical Classes:

  • Cytochrome P450 2C9 Inducers [MoA]
  • Cytochrome P450 3A Inducers [MoA]
  • Endothelin Receptor Antagonist [EPC]
  • Endothelin Receptor Antagonists [MoA]

Related Products:

Based on records with the same trade name.
  • 66215-101 Tracleer 62.5 mg Oral Tablet by Actelion Pharmaceuticals Us, Inc.
  • 66215-102 Tracleer 125 mg Oral Tablet by Actelion Pharmaceuticals Us, Inc.
  • 66215-232 Tracleer 32 mg Oral Tablet, Soluble by Actelion Pharmaceuticals Us, Inc.

NDC QR Code

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NDC 66215-103 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.