riociguat Oral Tablet

Brand(s)
Adempas
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bayer Healthcare Pharmaceuticals Inc. (2014-08-18)
Oldest Current Product
2013-10-08
License(s)
NDA
RxNORM
ORAL TABLET\RIOCIGUAT
FDAOB
ORAL\TABLET\RIOCIGUAT
SPL Active
ORAL\TABLET, FILM COATED\RIOCIGUAT
SPL Moiety
ORAL\TABLET, FILM COATED\RIOCIGUAT

product(s) by strength(s)

riociguat 0.5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504190250AdempasNDABayer Healthcare Pharmaceuticals Inc.2013-10-08RIOCIGUATORALTABLET, FILM COATEDNDA2048197b57509a-3d5d-41d4-8fed-1471e26372a3

riociguat 1 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504190251AdempasNDABayer Healthcare Pharmaceuticals Inc.2013-10-08RIOCIGUATORALTABLET, FILM COATEDNDA2048197b57509a-3d5d-41d4-8fed-1471e26372a3

riociguat 1.5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504190252AdempasNDABayer Healthcare Pharmaceuticals Inc.2013-10-08RIOCIGUATORALTABLET, FILM COATEDNDA2048197b57509a-3d5d-41d4-8fed-1471e26372a3

riociguat 2 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504190253AdempasNDABayer Healthcare Pharmaceuticals Inc.2013-10-08RIOCIGUATORALTABLET, FILM COATEDNDA2048197b57509a-3d5d-41d4-8fed-1471e26372a3

riociguat 2.5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504190254AdempasNDABayer Healthcare Pharmaceuticals Inc.2013-10-08RIOCIGUATORALTABLET, FILM COATEDNDA2048197b57509a-3d5d-41d4-8fed-1471e26372a3

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA204819ADEMPASBAYER HEALTHCARE PHARMACEUTICALS INC2013-10-08p7173037, SUBSTANCE
p6743798, SUBSTANCE
ORPHAN DRUG EXCLUSIVITY [2020-10-08]
NEW CHEMICAL ENTITY [2018-10-08]
NDA204819_001, NDA204819_002, NDA204819_003, NDA204819_004, NDA204819_005

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204819_001RXRIOCIGUAT (0.5MG)ORALTABLETFalse2013-10-08ADEMPAS
2NDA204819_002RXRIOCIGUAT (1MG)ORALTABLETFalse2013-10-08ADEMPAS
3NDA204819_003RXRIOCIGUAT (1.5MG)ORALTABLETFalse2013-10-08ADEMPAS
4NDA204819_004RXRIOCIGUAT (2MG)ORALTABLETFalse2013-10-08ADEMPAS
5NDA204819_005RXRIOCIGUAT (2.5MG)ORALTABLETTrue2013-10-08ADEMPAS

patent(s)

#idexpiration dateapplication(s)
1p6743798 (view patent)2019-07-16NDA204819
2p7173037 (view patent)2023-04-25NDA204819

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
17b57509a-3d5d-41d4-8fed-1471e26372a3 (view SPL)These highlights do not include all the information needed to use ADEMPAS safely and effectively. See full prescribing information for ADEMPAS.ADEMPAS (riociguat) tablets, for oral useInitial U.S. Approval: 2013prescriptionHuman PrescriptionBayer Healthcare Pharmaceuticals Inc.LABEL, MANUFACTURE, PACK2014-08-188504190250, 504190251, 504190252, 504190253, 504190254

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII