Ayvakit
These highlights do not include all the information needed to use AYVAKIT safely and effectively. See full prescribing information for AYVAKIT. AYVAKIT (avapritinib) tablets, for oral use Initial U.S. Approval: 2020
Approved
Approval ID
645c887c-8cd4-4623-8da9-ac223d71a8b9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 24, 2023
Manufacturers
FDA
Blueprint Medicines Corporation
DUNS: 021905363
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
avapritinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72064-110
Application NumberNDA212608
Product Classification
M
Marketing Category
C73594
G
Generic Name
avapritinib
Product Specifications
Route of AdministrationORAL
Effective DateMay 24, 2023
FDA Product Classification
INGREDIENTS (17)
Microcrystalline cellulose 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
avapritinibActive
Quantity: 100 mg in 1 1
Code: 513P80B4YJ
Classification: ACTIB
Microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
Copovidone K25-31Inactive
Code: D9C330MD8B
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Polyvinyl Alcohol (130000 MW)Inactive
Code: 660SZ0AKDA
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
Butyl AlcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Isopropyl AlcoholInactive
Code: ND2M416302
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
AmmoniaInactive
Code: 5138Q19F1X
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
Polyethylene Glycol 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
avapritinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72064-125
Application NumberNDA212608
Product Classification
M
Marketing Category
C73594
G
Generic Name
avapritinib
Product Specifications
Route of AdministrationORAL
Effective DateMay 24, 2023
FDA Product Classification
INGREDIENTS (10)
avapritinibActive
Quantity: 25 mg in 1 1
Code: 513P80B4YJ
Classification: ACTIB
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
Copovidone K25-31Inactive
Code: D9C330MD8B
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
Polyvinyl Alcohol (130000 MW)Inactive
Code: 660SZ0AKDA
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
avapritinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72064-150
Application NumberNDA212608
Product Classification
M
Marketing Category
C73594
G
Generic Name
avapritinib
Product Specifications
Route of AdministrationORAL
Effective DateMay 24, 2023
FDA Product Classification
INGREDIENTS (10)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
Copovidone K25-31Inactive
Code: D9C330MD8B
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
Polyvinyl Alcohol (130000 MW)Inactive
Code: 660SZ0AKDA
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
avapritinibActive
Quantity: 50 mg in 1 1
Code: 513P80B4YJ
Classification: ACTIB
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
avapritinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72064-130
Application NumberNDA212608
Product Classification
M
Marketing Category
C73594
G
Generic Name
avapritinib
Product Specifications
Route of AdministrationORAL
Effective DateMay 24, 2023
FDA Product Classification
INGREDIENTS (17)
avapritinibActive
Quantity: 300 mg in 1 1
Code: 513P80B4YJ
Classification: ACTIB
Microcrystalline cellulose 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
Microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
Copovidone K25-31Inactive
Code: D9C330MD8B
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
Polyethylene Glycol 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
Polyvinyl Alcohol (130000 MW)Inactive
Code: 660SZ0AKDA
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
Isopropyl AlcoholInactive
Code: ND2M416302
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Butyl AlcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
AmmoniaInactive
Code: 5138Q19F1X
Classification: IACT
avapritinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72064-120
Application NumberNDA212608
Product Classification
M
Marketing Category
C73594
G
Generic Name
avapritinib
Product Specifications
Route of AdministrationORAL
Effective DateMay 24, 2023
FDA Product Classification
INGREDIENTS (17)
Microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
avapritinibActive
Quantity: 200 mg in 1 1
Code: 513P80B4YJ
Classification: ACTIB
Microcrystalline cellulose 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
Copovidone K25-31Inactive
Code: D9C330MD8B
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Polyethylene Glycol 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
Polyvinyl Alcohol (130000 MW)Inactive
Code: 660SZ0AKDA
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Isopropyl AlcoholInactive
Code: ND2M416302
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
AmmoniaInactive
Code: 5138Q19F1X
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Butyl AlcoholInactive
Code: 8PJ61P6TS3
Classification: IACT