66215-501 : Opsumit (Macitentan 10 mg)
| NDC: | 66215-501 |
| Labeler: | Actelion Pharmaceuticals Us, Inc. |
| Product Type: | Human Prescription Drug |
| Drug Name: |  Opsumit |
| Dosage Form: | Oral Tablet, Film Coated |
| Application #: | NDA204410 |
| Rev. Date: |
Appearance:
| Markings: | 10 |
| Shapes: |
Round |
| 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:
- 66215-501-15: 1 BLISTER PACK IN 1 CARTON (66215‑501‑15) > 15 TABLET, FILM COATED IN 1 BLISTER PACK
- 66215-501-30: 1 BOTTLE IN 1 CARTON (66215‑501‑30) > 30 TABLET, FILM COATED IN 1 BOTTLE
Active Ingredients:
- Macitentan
Dosage Strength:
- 10 mg
Inactive Ingredients:
- Lactose Monohydrate
- Cellulose, Microcrystalline
- Sodium Starch Glycolate Type a Potato
- Povidones
- Magnesium Stearate
- Polysorbate 80
Pharmaceutical Classes:
- Endothelin Receptor Antagonist [EPC]
- Endothelin Receptor Antagonists [MoA]
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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.