UPTRAVI
These highlights do not include all the information needed to use UPTRAVI safely and effectively. See full prescribing information for UPTRAVI. UPTRAVI (selexipag) tablets, for oral use UPTRAVI (selexipag) for injection, for intravenous use Initial U.S. Approval: 2015
Approved
Approval ID
a7a23b87-f892-4e2c-8e2e-ebf841220f90
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 19, 2023
Manufacturers
FDA
Actelion Pharmaceuticals US, Inc.
DUNS: 002641228
Products 10
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Selexipag
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66215-628
Application NumberNDA207947
Product Classification
M
Marketing Category
C73594
G
Generic Name
Selexipag
Product Specifications
Effective DateApril 19, 2023
FDA Product Classification
Selexipag
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66215-718
Application NumberNDA214275
Product Classification
M
Marketing Category
C73594
G
Generic Name
Selexipag
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 19, 2023
FDA Product Classification
INGREDIENTS (5)
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SELEXIPAGActive
Quantity: 1800 ug in 10 mL
Code: 5EXC0E384L
Classification: ACTIB
Selexipag
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66215-608
Application NumberNDA207947
Product Classification
M
Marketing Category
C73594
G
Generic Name
Selexipag
Product Specifications
Route of AdministrationORAL
Effective DateApril 19, 2023
FDA Product Classification
INGREDIENTS (12)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 WAMW)Inactive
Code: U3JF91U133
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SELEXIPAGActive
Quantity: 800 ug in 1 1
Code: 5EXC0E384L
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Selexipag
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66215-602
Application NumberNDA207947
Product Classification
M
Marketing Category
C73594
G
Generic Name
Selexipag
Product Specifications
Route of AdministrationORAL
Effective DateApril 19, 2023
FDA Product Classification
INGREDIENTS (11)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
SELEXIPAGActive
Quantity: 200 ug in 1 1
Code: 5EXC0E384L
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 WAMW)Inactive
Code: U3JF91U133
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
Selexipag
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66215-606
Application NumberNDA207947
Product Classification
M
Marketing Category
C73594
G
Generic Name
Selexipag
Product Specifications
Route of AdministrationORAL
Effective DateApril 19, 2023
FDA Product Classification
INGREDIENTS (12)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 WAMW)Inactive
Code: U3JF91U133
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SELEXIPAGActive
Quantity: 600 ug in 1 1
Code: 5EXC0E384L
Classification: ACTIB
Selexipag
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66215-612
Application NumberNDA207947
Product Classification
M
Marketing Category
C73594
G
Generic Name
Selexipag
Product Specifications
Route of AdministrationORAL
Effective DateApril 19, 2023
FDA Product Classification
INGREDIENTS (12)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 WAMW)Inactive
Code: U3JF91U133
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
SELEXIPAGActive
Quantity: 1200 ug in 1 1
Code: 5EXC0E384L
Classification: ACTIB
Selexipag
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66215-610
Application NumberNDA207947
Product Classification
M
Marketing Category
C73594
G
Generic Name
Selexipag
Product Specifications
Route of AdministrationORAL
Effective DateApril 19, 2023
FDA Product Classification
INGREDIENTS (12)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 WAMW)Inactive
Code: U3JF91U133
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SELEXIPAGActive
Quantity: 1000 ug in 1 1
Code: 5EXC0E384L
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Selexipag
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66215-616
Application NumberNDA207947
Product Classification
M
Marketing Category
C73594
G
Generic Name
Selexipag
Product Specifications
Route of AdministrationORAL
Effective DateApril 19, 2023
FDA Product Classification
INGREDIENTS (13)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 WAMW)Inactive
Code: U3JF91U133
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SELEXIPAGActive
Quantity: 1600 ug in 1 1
Code: 5EXC0E384L
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Selexipag
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66215-614
Application NumberNDA207947
Product Classification
M
Marketing Category
C73594
G
Generic Name
Selexipag
Product Specifications
Route of AdministrationORAL
Effective DateApril 19, 2023
FDA Product Classification
INGREDIENTS (11)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 WAMW)Inactive
Code: U3JF91U133
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SELEXIPAGActive
Quantity: 1400 ug in 1 1
Code: 5EXC0E384L
Classification: ACTIB
Selexipag
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66215-604
Application NumberNDA207947
Product Classification
M
Marketing Category
C73594
G
Generic Name
Selexipag
Product Specifications
Route of AdministrationORAL
Effective DateApril 19, 2023
FDA Product Classification
INGREDIENTS (11)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 WAMW)Inactive
Code: U3JF91U133
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
SELEXIPAGActive
Quantity: 400 ug in 1 1
Code: 5EXC0E384L
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT