INPEFA
These highlights do not include all the information needed to use INPEFA safely and effectively. See full prescribing information for INPEFA.INPEFA (sotagliflozin) tablets, for oral useInitial U.S. Approval: 2023
Approved
Approval ID
1a46614e-05f6-421a-b6f4-d6f8760d643a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 15, 2024
Manufacturers
FDA
Lexicon Pharmaceuticals, Inc.
DUNS: 838179638
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sotagliflozin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70183-240
Application NumberNDA216203
Product Classification
M
Marketing Category
C73594
G
Generic Name
sotagliflozin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 15, 2024
FDA Product Classification
INGREDIENTS (12)
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
sotagliflozinActive
Quantity: 400 mg in 1 1
Code: 6B4ZBS263Y
Classification: ACTIB
Microcrystalline cellulose 102Inactive
Code: PNR0YF693Y
Classification: IACT
Microcrystalline cellulose 200Inactive
Code: 5XDI2TS1EZ
Classification: IACT
Croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
sotagliflozin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70183-220
Application NumberNDA216203
Product Classification
M
Marketing Category
C73594
G
Generic Name
sotagliflozin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 15, 2024
FDA Product Classification
INGREDIENTS (11)
sotagliflozinActive
Quantity: 200 mg in 1 1
Code: 6B4ZBS263Y
Classification: ACTIB
Microcrystalline cellulose 102Inactive
Code: PNR0YF693Y
Classification: IACT
Microcrystalline cellulose 200Inactive
Code: 5XDI2TS1EZ
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
polyvinyl alcohol, unspecifiedInactive
Code: 532B59J990
Classification: IACT
polyethylene glycol, unspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
sotagliflozin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70183-221
Application NumberNDA216203
Product Classification
M
Marketing Category
C73594
G
Generic Name
sotagliflozin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 15, 2024
FDA Product Classification
INGREDIENTS (11)
sotagliflozinActive
Quantity: 200 mg in 1 1
Code: 6B4ZBS263Y
Classification: ACTIB
Microcrystalline cellulose 200Inactive
Code: 5XDI2TS1EZ
Classification: IACT
Microcrystalline cellulose 102Inactive
Code: PNR0YF693Y
Classification: IACT
Croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polyvinyl alcohol, unspecifiedInactive
Code: 532B59J990
Classification: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
polyethylene glycol, unspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
sotagliflozin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70183-241
Application NumberNDA216203
Product Classification
M
Marketing Category
C73594
G
Generic Name
sotagliflozin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 15, 2024
FDA Product Classification
INGREDIENTS (12)
sotagliflozinActive
Quantity: 400 mg in 1 1
Code: 6B4ZBS263Y
Classification: ACTIB
Microcrystalline cellulose 102Inactive
Code: PNR0YF693Y
Classification: IACT
Microcrystalline cellulose 200Inactive
Code: 5XDI2TS1EZ
Classification: IACT
Croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT