Zydelig
These highlights do not include all the information needed to use ZYDELIG safely and effectively. See full prescribing information for ZYDELIG. ZYDELIG® (idelalisib) tablets, for oral use Initial U.S. Approval: 2014
Approved
Approval ID
efbdafa9-d18c-4e85-b4a2-1e620fc74e50
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 1, 2022
Manufacturers
FDA
Gilead Sciences, Inc.
DUNS: 185049848
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
idelalisib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61958-1701
Application NumberNDA205858
Product Classification
M
Marketing Category
C73594
G
Generic Name
idelalisib
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2022
FDA Product Classification
INGREDIENTS (12)
IDELALISIBActive
Quantity: 100 mg in 1 1
Code: YG57I8T5M0
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
idelalisib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61958-1702
Application NumberNDA205858
Product Classification
M
Marketing Category
C73594
G
Generic Name
idelalisib
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2022
FDA Product Classification
INGREDIENTS (11)
IDELALISIBActive
Quantity: 150 mg in 1 1
Code: YG57I8T5M0
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT