Adempas
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: 2013
Approved
Approval ID
7b57509a-3d5d-41d4-8fed-1471e26372a3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2023
Manufacturers
FDA
Bayer HealthCare Pharmaceuticals Inc.
DUNS: 005436809
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
riociguat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50419-253
Application NumberNDA204819
Product Classification
M
Marketing Category
C73594
G
Generic Name
riociguat
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2021
FDA Product Classification
INGREDIENTS (12)
RIOCIGUATActive
Quantity: 2 mg in 1 1
Code: RU3FE2Y4XI
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
riociguat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50419-250
Application NumberNDA204819
Product Classification
M
Marketing Category
C73594
G
Generic Name
riociguat
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2021
FDA Product Classification
INGREDIENTS (10)
RIOCIGUATActive
Quantity: .5 mg in 1 1
Code: RU3FE2Y4XI
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
riociguat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50419-254
Application NumberNDA204819
Product Classification
M
Marketing Category
C73594
G
Generic Name
riociguat
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2021
FDA Product Classification
INGREDIENTS (12)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
RIOCIGUATActive
Quantity: 2.5 mg in 1 1
Code: RU3FE2Y4XI
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
riociguat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50419-252
Application NumberNDA204819
Product Classification
M
Marketing Category
C73594
G
Generic Name
riociguat
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2021
FDA Product Classification
INGREDIENTS (11)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
RIOCIGUATActive
Quantity: 1.5 mg in 1 1
Code: RU3FE2Y4XI
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
riociguat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50419-251
Application NumberNDA204819
Product Classification
M
Marketing Category
C73594
G
Generic Name
riociguat
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2021
FDA Product Classification
INGREDIENTS (11)
RIOCIGUATActive
Quantity: 1 mg in 1 1
Code: RU3FE2Y4XI
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT