NDC 66215-612

UPTRAVI

Selexipag

UPTRAVI is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Actelion Pharmaceuticals Us, Inc.. The primary component is Selexipag.

• Product ID: 66215-612_32a13445-38fd-4dcd-b2e1-e84b7c11d4b6
• NDC: 66215-612
• Product Type: Human Prescription Drug
• Proprietary Name: UPTRAVI
• Generic Name: Selexipag
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2015-12-21
• Marketing Category: NDA / NDA
• Application Number: NDA207947
• Labeler Name: Actelion Pharmaceuticals US, Inc.
• Substance Name: SELEXIPAG
• Active Ingredient Strength: 1200 ug/1
• Pharm Classes: Prostacyclin Receptor Agonist [EPC],Prostacyclin Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 66215-612-06

1 BOTTLE in 1 CARTON (66215-612-06) > 60 TABLET, COATED in 1 BOTTLE

• Marketing Start Date: 2015-12-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66215-612-06 [66215061206]

UPTRAVI TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA207947
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-12-21

Drug Details

Active Ingredients

Ingredient	Strength
SELEXIPAG	1200 ug/1

OpenFDA Data

• SPL SET ID: a7a23b87-f892-4e2c-8e2e-ebf841220f90
• Manufacturer:
  • Actelion Pharmaceuticals US, Inc.
• UNII:
  • 5EXC0E384L
• RxNorm Concept Unique ID - RxCUI:
  • 1729007
  • 1729063
  • 1729059
  • 1729065
  • 1729075
  • 1729061
  • 1729055
  • 1729057
  • 1729051
  • 1729047
  • 1729053
  • 1729045
  • 1729029
  • 1729013
  • 1729027
  • 1729033
  • 1729031
  • 1729076

Pharmacological Class

• Prostacyclin Receptor Agonist [EPC]
• Prostacyclin Receptor Agonists [MoA]

NDC Crossover Matching brand name "UPTRAVI" or generic name "Selexipag"

NDC	Brand Name	Generic Name
66215-602	UPTRAVI	Selexipag
66215-604	UPTRAVI	Selexipag
66215-606	UPTRAVI	Selexipag
66215-608	UPTRAVI	Selexipag
66215-610	UPTRAVI	Selexipag
66215-612	UPTRAVI	UPTRAVI
66215-614	UPTRAVI	UPTRAVI
66215-616	UPTRAVI	UPTRAVI