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
NDC Product Code61958-1701
Application NumberNDA205858
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateFebruary 28, 2022
Generic Nameidelalisib
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
NDC Product Code61958-1702
Application NumberNDA205858
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateFebruary 28, 2022
Generic Nameidelalisib
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