TUKYSA
These highlights do not include all the information needed to use TUKYSA safely and effectively. See full prescribing information for TUKYSA. TUKYSA (tucatinib) tablets, for oral use Initial U.S. Approval: 2020
Approved
Approval ID
f27eb1b9-b7fc-424e-988f-84dd7bb195a3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 2023
Manufacturers
FDA
SEAGEN INC.
DUNS: 028484371
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tucatinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51144-001
Application NumberNDA213411
Product Classification
M
Marketing Category
C73594
G
Generic Name
tucatinib
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 26, 2023
FDA Product Classification
INGREDIENTS (14)
Copovidone K25-31Inactive
Code: D9C330MD8B
Classification: IACT
TucatinibActive
Quantity: 50 mg in 1 1
Code: 234248D0HH
Classification: ACTIB
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Crospovidone (120 .Mu.M)Inactive
Code: 68401960MK
Classification: IACT
Sodium BicarbonateInactive
Code: 8MDF5V39QO
Classification: IACT
Potassium ChlorideInactive
Code: 660YQ98I10
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Polyvinyl Alcohol, UnspecifiedInactive
Code: 532B59J990
Classification: IACT
Microcrystalline Cellulose 102Inactive
Code: PNR0YF693Y
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
tucatinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51144-002
Application NumberNDA213411
Product Classification
M
Marketing Category
C73594
G
Generic Name
tucatinib
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 26, 2023
FDA Product Classification
INGREDIENTS (14)
Crospovidone (120 .Mu.M)Inactive
Code: 68401960MK
Classification: IACT
TucatinibActive
Quantity: 150 mg in 1 1
Code: 234248D0HH
Classification: ACTIB
Copovidone K25-31Inactive
Code: D9C330MD8B
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
Sodium BicarbonateInactive
Code: 8MDF5V39QO
Classification: IACT
Microcrystalline Cellulose 102Inactive
Code: PNR0YF693Y
Classification: IACT
Polyvinyl Alcohol, UnspecifiedInactive
Code: 532B59J990
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Potassium ChlorideInactive
Code: 660YQ98I10
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT