AKYNZEO
These highlights do not include all the information needed to use AKYNZEO® safely and effectively. See full prescribing information for AKYNZEO®. AKYNZEO® (netupitant and palonosetron) capsules, for oral use Initial U.S. Approval: 2014AKYNZEO® (fosnetupitant and palonosetron) for injection, for intravenous useInitial U.S. Approval: 2018
Approved
Approval ID
8e47618e-af46-4d82-94e8-1507c042252d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 2023
Manufacturers
FDA
Helsinn Therapeutics (U.S.), Inc.
DUNS: 829472583
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fosnetupitant and Palonosetron
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69639-102
Application NumberNDA210493
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fosnetupitant and Palonosetron
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 10, 2023
FDA Product Classification
INGREDIENTS (6)
PALONOSETRON HYDROCHLORIDEActive
Quantity: 0.28 mg in 1 1
Code: 23310D4I19
Classification: ACTIM
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
FOSNETUPITANTActive
Quantity: 260 mg in 1 1
Code: T672P80L2S
Classification: ACTIM
Fosnetupitant and Palonosetron
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69639-105
Application NumberNDA210493
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fosnetupitant and Palonosetron
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 10, 2023
FDA Product Classification
INGREDIENTS (7)
FOSNETUPITANTActive
Quantity: 260 mg in 20 mL
Code: T672P80L2S
Classification: ACTIM
PALONOSETRON HYDROCHLORIDEActive
Quantity: 0.28 mg in 20 mL
Code: 23310D4I19
Classification: ACTIM
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Fosnetupitant and Palonosetron
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69639-106
Application NumberNDA210493
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fosnetupitant and Palonosetron
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 10, 2023
FDA Product Classification
INGREDIENTS (7)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
PALONOSETRON HYDROCHLORIDEActive
Quantity: 0.28 mg in 20 mL
Code: 23310D4I19
Classification: ACTIM
FOSNETUPITANTActive
Quantity: 260 mg in 20 mL
Code: T672P80L2S
Classification: ACTIM
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Netupitant and Palonosetron
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69639-101
Application NumberNDA205718
Product Classification
M
Marketing Category
C73594
G
Generic Name
Netupitant and Palonosetron
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 10, 2023
FDA Product Classification
INGREDIENTS (19)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYGLYCERYL-3 DIOLEATEInactive
Code: D08AL46IU2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PALONOSETRONActive
Quantity: 0.5 mg in 1 1
Code: 5D06587D6R
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SUCROSE LAURATEInactive
Code: 05Q7CD0E49
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
CAPRYLIC/CAPRIC MONO/DIGLYCERIDESInactive
Code: U72Q2I8C85
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
NETUPITANTActive
Quantity: 300 mg in 1 1
Code: 7732P08TIR
Classification: ACTIB