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NDC 66215-0501-30 OPSUMIT 10 mg/1 Details
OPSUMIT 10 mg/1
OPSUMIT is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Actelion Pharmaceuticals US, Inc.. The primary component is MACITENTAN.
MedlinePlus Drug Summary
Macitentan is used to manage the symptoms of pulmonary arterial hypertension (PAH; high blood pressure in the vessels that carry blood to the lungs). Macitentan is in a class of medications called endothelin receptor antagonists. It works by stopping the action of endothelin, a natural substance that causes blood vessels to narrow and prevents normal blood flow in people who have PAH.
Related Packages: 66215-0501-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Macitentan
Product Information
| NDC | 66215-0501 |
|---|---|
| Product ID | 66215-501_fe1c280f-5053-ee0f-e053-6294a90a1489 |
| Associated GPIs | 40160050000320 |
| GCN Sequence Number | 071567 |
| GCN Sequence Number Description | macitentan TABLET 10 MG ORAL |
| HIC3 | B1B |
| HIC3 Description | PULMONARY ANTI-HTN, ENDOTHELIN RECEPTOR ANTAGONIST |
| GCN | 35443 |
| HICL Sequence Number | 040677 |
| HICL Sequence Number Description | MACITENTAN |
| Brand/Generic | Brand |
| Proprietary Name | OPSUMIT |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | macitentan |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | MACITENTAN |
| Labeler Name | Actelion Pharmaceuticals US, Inc. |
| Pharmaceutical Class | Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA204410 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 66215-0501-30 (66215050130)
| NDC Package Code | 66215-501-30 |
|---|---|
| Billing NDC | 66215050130 |
| Package | 1 BOTTLE in 1 CARTON (66215-501-30) / 30 TABLET, FILM COATED in 1 BOTTLE |
| Marketing Start Date | 2013-11-04 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |