RETEVMO
These highlights do not include all the information needed to use RETEVMO safely and effectively. See full prescribing information for RETEVMO.RETEVMO (selpercatinib) capsules, for oral useInitial U.S. Approval: 2020
Approved
Approval ID
7fa848ba-a59c-4144-9f52-64d090f4d828
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 28, 2023
Manufacturers
FDA
Eli Lilly and Company
DUNS: 006421325
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
selpercatinib
PRODUCT DETAILS
NDC Product Code0002-3977
Application NumberNDA213246
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateSeptember 21, 2022
Generic Nameselpercatinib
INGREDIENTS (14)
selpercatinibActive
Quantity: 40 mg in 1 1
Code: CEGM9YBNGD
Classification: ACTIB
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
gelatin, unspecifiedInactive
Code: 2G86QN327L
Classification: IACT
ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT
isopropyl alcoholInactive
Code: ND2M416302
Classification: IACT
ammoniaInactive
Code: 5138Q19F1X
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
butyl alcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
potassium hydroxideInactive
Code: WZH3C48M4T
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
selpercatinib
PRODUCT DETAILS
NDC Product Code0002-2980
Application NumberNDA213246
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateSeptember 21, 2022
Generic Nameselpercatinib
INGREDIENTS (15)
selpercatinibActive
Quantity: 80 mg in 1 1
Code: CEGM9YBNGD
Classification: ACTIB
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
gelatin, unspecifiedInactive
Code: 2G86QN327L
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
isopropyl alcoholInactive
Code: ND2M416302
Classification: IACT
butyl alcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
ammoniaInactive
Code: 5138Q19F1X
Classification: IACT
potassium hydroxideInactive
Code: WZH3C48M4T
Classification: IACT
ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT