ENSACOVE
ENSACOVE (ensartinib) capsules, for oral use
Approved
Approval ID
1e1b2f79-678a-472a-b924-66909c8a4b2e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 26, 2024
Manufacturers
FDA
Xcovery Holdings, Inc.
DUNS: 033440609
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ensartinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code83076-1100
Application NumberNDA218171
Product Classification
M
Marketing Category
C73594
G
Generic Name
ensartinib
Product Specifications
Route of AdministrationORAL
Effective DateDecember 26, 2024
FDA Product Classification
INGREDIENTS (16)
ENSARTINIB HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: C2FR6VT1BQ
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
DEHYDRATED ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ensartinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code83076-1025
Application NumberNDA218171
Product Classification
M
Marketing Category
C73594
G
Generic Name
ensartinib
Product Specifications
Route of AdministrationORAL
Effective DateDecember 26, 2024
FDA Product Classification
INGREDIENTS (12)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
DEHYDRATED ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ENSARTINIB HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: C2FR6VT1BQ
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT