NDC 66215-501

OPSUMIT

Macitentan

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.

• Product ID: 66215-501_07c8e555-9129-44ae-ab83-5f09ad989420
• NDC: 66215-501
• Product Type: Human Prescription Drug
• Proprietary Name: OPSUMIT
• Generic Name: Macitentan
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2013-11-04
• Marketing Category: NDA / NDA
• Application Number: NDA204410
• Labeler Name: Actelion Pharmaceuticals US, Inc.
• Substance Name: MACITENTAN
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 66215-501-15

1 BLISTER PACK in 1 CARTON (66215-501-15) > 15 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2013-11-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66215-501-30 [66215050130]

OPSUMIT TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204410
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-11-04

NDC 66215-501-15 [66215050115]

OPSUMIT TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204410
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-11-04

Drug Details

Active Ingredients

Ingredient	Strength
MACITENTAN	10 mg/1

OpenFDA Data

• SPL SET ID: 1e484a50-55db-4b85-8c57-6cd1b0353abd
• Manufacturer:
  • Actelion Pharmaceuticals US, Inc.
• UNII:
  • Z9K9Y9WMVL
• RxNorm Concept Unique ID - RxCUI:
  • 1442143
  • 1442137

Pharmacological Class

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