66215-101 : Tracleer 62.5 mg Oral Tablet
| NDC: | 66215-101 |
| Labeler: | Actelion Pharmaceuticals Us, Inc. |
| Product Type: | Human Prescription Drug |
| Drug Name: |  Tracleer |
| Dosage Form: | Oral Tablet, Film Coated |
| Application #: | NDA021290 |
| Rev. Date: |
Appearance:
| Markings: | 62;5 |
| Shapes: |
Oval |
| Colors: |
 White |
| Size (mm): | 6 |
| 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:
- 66215-101-03: 10 BLISTER PACK IN 1 CARTON (66215‑101‑03) > 3 TABLET, FILM COATED IN 1 BLISTER PACK
- 66215-101-06: 1 BOTTLE, PLASTIC IN 1 CARTON (66215‑101‑06) > 60 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC
Active Ingredients:
- Bosentan
Dosage Strength:
- 62.5 mg
Inactive Ingredients:
- Starch, Corn
- Sodium Starch Glycolate Type a Potato
- Povidone K90
- Glyceryl Dibehenate
- Magnesium Stearate
- Hypromelloses
- Triacetin
- Talc
- Titanium Dioxide
- Ferric Oxide Yellow
- Ferric Oxide Red
- Ethylcelluloses
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.- 66215-102 Tracleer 125 mg Oral Tablet by Actelion Pharmaceuticals Us, Inc.
- 66215-103 Tracleer 32 mg Oral Tablet, Soluble by Actelion Pharmaceuticals Us, Inc.
- 66215-232 Tracleer 32 mg Oral Tablet, Soluble by Actelion Pharmaceuticals Us, Inc.
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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.