OXBRYTA
These highlights do not include all the information needed to use OXBRYTA safely and effectively. See full prescribing information for OXBRYTA. OXBRYTA (voxelotor) tablets, for oral use OXBRYTA (voxelotor) tablets for oral suspension Initial U.S. Approval: 2019
Approved
Approval ID
3c557fac-29ec-483f-b691-8a935d4decc3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 26, 2023
Manufacturers
FDA
Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc.
DUNS: 028636495
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Voxelotor
PRODUCT DETAILS
NDC Product Code72786-111
Application NumberNDA216157
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 21, 2023
Generic NameVoxelotor
INGREDIENTS (9)
VoxelotorActive
Quantity: 300 mg in 1 1
Code: 3ZO554A4Q8
Classification: ACTIB
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
SucraloseInactive
Code: 96K6UQ3ZD4
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
AcaciaInactive
Code: 5C5403N26O
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Voxelotor
PRODUCT DETAILS
NDC Product Code72786-101
Application NumberNDA213137
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 21, 2023
Generic NameVoxelotor
INGREDIENTS (11)
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Polyethylene glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
VoxelotorActive
Quantity: 500 mg in 1 1
Code: 3ZO554A4Q8
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Voxelotor
PRODUCT DETAILS
NDC Product Code72786-102
Application NumberNDA213137
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 21, 2023
Generic NameVoxelotor
INGREDIENTS (12)
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
Polyethylene glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
VoxelotorActive
Quantity: 300 mg in 1 1
Code: 3ZO554A4Q8
Classification: ACTIB
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT