NDC 50419-251

Adempas

Riociguat

Adempas is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bayer Healthcare Pharmaceuticals Inc.. The primary component is Riociguat.

Product ID50419-251_12583df4-9db2-4d88-b104-bb49b28e54ff
NDC50419-251
Product TypeHuman Prescription Drug
Proprietary NameAdempas
Generic NameRiociguat
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2013-10-08
Marketing CategoryNDA / NDA
Application NumberNDA204819
Labeler NameBayer HealthCare Pharmaceuticals Inc.
Substance NameRIOCIGUAT
Active Ingredient Strength1 mg/1
Pharm ClassesGuanylate Cyclase Stimulators [MoA],Soluble Guanylate Cyclase Stimulator [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50419-251-01

90 TABLET, FILM COATED in 1 BOTTLE (50419-251-01)
Marketing Start Date2013-10-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50419-251-91 [50419025191]

Adempas TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA204819
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-09-18

NDC 50419-251-01 [50419025101]

Adempas TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA204819
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-10-08

NDC 50419-251-03 [50419025103]

Adempas TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA204819
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-10-08

Drug Details

Active Ingredients

IngredientStrength
RIOCIGUAT1 mg/1

OpenFDA Data

SPL SET ID:7b57509a-3d5d-41d4-8fed-1471e26372a3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1439894
  • 1439896
  • 1439899
  • 1439903
  • 1439901
  • 1439837
  • 1439833
  • 1439821
  • 1439831
  • 1439823
  • Pharmacological Class

    • Guanylate Cyclase Stimulators [MoA]
    • Soluble Guanylate Cyclase Stimulator [EPC]

    NDC Crossover Matching brand name "Adempas" or generic name "Riociguat"

    NDCBrand NameGeneric Name
    50419-250Adempasriociguat
    50419-251Adempasriociguat
    50419-252Adempasriociguat
    50419-253Adempasriociguat
    50419-254Adempasriociguat

    Trademark Results [Adempas]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ADEMPAS
    ADEMPAS
    77723142 3718134 Live/Registered
    Bayer Aktiengesellschaft
    2009-04-27

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