Jesduvroq
These highlights do not include all the information needed to use JESDUVROQ safely and effectively. See full prescribing information for JESDUVROQ.JESDUVROQ (daprodustat) tablets, for oral useInitial U.S. Approval: 2023
Approved
Approval ID
d82aa06e-5a33-4844-99b7-4701313455a4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 30, 2023
Manufacturers
FDA
GlaxoSmithKline LLC
DUNS: 167380711
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
daprodustat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0897
Application NumberNDA216951
Product Classification
M
Marketing Category
C73594
G
Generic Name
daprodustat
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (12)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DAPRODUSTATActive
Quantity: 1 mg in 1 1
Code: JVR38ZM64B
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
daprodustat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0906
Application NumberNDA216951
Product Classification
M
Marketing Category
C73594
G
Generic Name
daprodustat
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (9)
DAPRODUSTATActive
Quantity: 4 mg in 1 1
Code: JVR38ZM64B
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
daprodustat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0911
Application NumberNDA216951
Product Classification
M
Marketing Category
C73594
G
Generic Name
daprodustat
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (12)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
DAPRODUSTATActive
Quantity: 6 mg in 1 1
Code: JVR38ZM64B
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
daprodustat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0914
Application NumberNDA216951
Product Classification
M
Marketing Category
C73594
G
Generic Name
daprodustat
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (11)
DAPRODUSTATActive
Quantity: 8 mg in 1 1
Code: JVR38ZM64B
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
daprodustat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0903
Application NumberNDA216951
Product Classification
M
Marketing Category
C73594
G
Generic Name
daprodustat
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (12)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
DAPRODUSTATActive
Quantity: 2 mg in 1 1
Code: JVR38ZM64B
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT