Lamotrigine
These highlights do not include all the information needed to use LAMOTRIGINE TABLETS FOR ORAL SUSPENSION safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS FOR ORAL SUSPENSION. LAMOTRIGINE tablets for oral suspension Initial U.S. Approval: 1994
Approved
Approval ID
f54690b3-bcbb-4d94-95b9-b7591af00117
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 16, 2023
Manufacturers
FDA
Rising Pharma Holdings, Inc.
DUNS: 116880195
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lamotrigine
PRODUCT DETAILS
NDC Product Code16571-786
Application NumberANDA090401
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 16, 2023
Generic NameLamotrigine
INGREDIENTS (7)
LAMOTRIGINEActive
Quantity: 25 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
Lamotrigine
PRODUCT DETAILS
NDC Product Code16571-785
Application NumberANDA090401
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 16, 2023
Generic NameLamotrigine
INGREDIENTS (7)
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
LAMOTRIGINEActive
Quantity: 5 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT