Lamotrigine
These highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE tablets, for oral use Initial U.S. Approval: 1994
Approved
Approval ID
7462b376-1b99-4e7f-826c-0f35368dd8be
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 16, 2023
Manufacturers
FDA
NorthStar Rx LLC
DUNS: 830546433
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lamotrigine
PRODUCT DETAILS
NDC Product Code16714-700
Application NumberANDA078956
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 16, 2023
Generic NameLamotrigine
INGREDIENTS (6)
LAMOTRIGINEActive
Quantity: 25 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Lamotrigine
PRODUCT DETAILS
NDC Product Code16714-702
Application NumberANDA078956
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 16, 2023
Generic NameLamotrigine
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LAMOTRIGINEActive
Quantity: 150 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Lamotrigine
PRODUCT DETAILS
NDC Product Code16714-701
Application NumberANDA078956
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 16, 2023
Generic NameLamotrigine
INGREDIENTS (7)
LAMOTRIGINEActive
Quantity: 100 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Lamotrigine
PRODUCT DETAILS
NDC Product Code16714-703
Application NumberANDA078956
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 16, 2023
Generic NameLamotrigine
INGREDIENTS (7)
LAMOTRIGINEActive
Quantity: 200 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT