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 ID66215-612_32a13445-38fd-4dcd-b2e1-e84b7c11d4b6
NDC66215-612
Product TypeHuman Prescription Drug
Proprietary NameUPTRAVI
Generic NameSelexipag
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2015-12-21
Marketing CategoryNDA / NDA
Application NumberNDA207947
Labeler NameActelion Pharmaceuticals US, Inc.
Substance NameSELEXIPAG
Active Ingredient Strength1200 ug/1
Pharm ClassesProstacyclin Receptor Agonist [EPC],Prostacyclin Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 66215-612-06

1 BOTTLE in 1 CARTON (66215-612-06) > 60 TABLET, COATED in 1 BOTTLE
Marketing Start Date2015-12-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66215-612-06 [66215061206]

UPTRAVI TABLET, COATED
Marketing CategoryNDA
Application NumberNDA207947
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-21

Drug Details

Active Ingredients

IngredientStrength
SELEXIPAG1200 ug/1

OpenFDA Data

SPL SET ID:a7a23b87-f892-4e2c-8e2e-ebf841220f90
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    66215-602UPTRAVISelexipag
    66215-604UPTRAVISelexipag
    66215-606UPTRAVISelexipag
    66215-608UPTRAVISelexipag
    66215-610UPTRAVISelexipag
    66215-612UPTRAVIUPTRAVI
    66215-614UPTRAVIUPTRAVI
    66215-616UPTRAVIUPTRAVI

    Trademark Results [UPTRAVI]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    UPTRAVI
    UPTRAVI
    86829111 5074971 Live/Registered
    Actelion Pharmaceuticals Ltd
    2015-11-23
    UPTRAVI
    UPTRAVI
    85348761 4087965 Live/Registered
    Actelion Pharmaceuticals Ltd
    2011-06-17

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