LAMICTAL
These highlights do not include all the information needed to use LAMICTAL safely and effectively. See full prescribing information for LAMICTAL. LAMICTAL (lamotrigine) tablets, for oral useLAMICTAL (lamotrigine) tablets for oral suspensionLAMICTAL ODT (lamotrigine) orally disintegrating tablets, for oral useInitial U.S. Approval: 1994
Approved
Approval ID
d7e3572d-56fe-4727-2bb4-013ccca22678
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 9, 2023
Manufacturers
FDA
GlaxoSmithKline LLC
DUNS: 167380711
Products 10
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lamotrigine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0644
Application NumberNDA020241
Product Classification
M
Marketing Category
C73594
G
Generic Name
lamotrigine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2021
FDA Product Classification
INGREDIENTS (7)
LAMOTRIGINEActive
Quantity: 200 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
lamotrigine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0526
Application NumberNDA020764
Product Classification
M
Marketing Category
C73594
G
Generic Name
lamotrigine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2021
FDA Product Classification
INGREDIENTS (8)
LAMOTRIGINEActive
Quantity: 5 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
lamotrigine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0780
Application NumberNDA022251
Product Classification
M
Marketing Category
C73594
G
Generic Name
lamotrigine
Product Specifications
Effective DateMarch 31, 2021
FDA Product Classification
lamotrigine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0778
Application NumberNDA022251
Product Classification
M
Marketing Category
C73594
G
Generic Name
lamotrigine
Product Specifications
Effective DateMarch 31, 2021
FDA Product Classification
lamotrigine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0633
Application NumberNDA020241
Product Classification
M
Marketing Category
C73594
G
Generic Name
lamotrigine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2021
FDA Product Classification
INGREDIENTS (6)
LAMOTRIGINEActive
Quantity: 25 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
lamotrigine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0777
Application NumberNDA022251
Product Classification
M
Marketing Category
C73594
G
Generic Name
lamotrigine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2021
FDA Product Classification
INGREDIENTS (5)
LAMOTRIGINEActive
Quantity: 200 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
ETHYLCELLULOSE (100 MPA.S)Inactive
Code: 47MLB0F1MV
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
lamotrigine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0699
Application NumberNDA020764
Product Classification
M
Marketing Category
C73594
G
Generic Name
lamotrigine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2021
FDA Product Classification
INGREDIENTS (8)
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
LAMOTRIGINEActive
Quantity: 2 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
lamotrigine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0817
Application NumberNDA020241
Product Classification
M
Marketing Category
C73594
G
Generic Name
lamotrigine
Product Specifications
Effective DateMarch 31, 2021
FDA Product Classification
lamotrigine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0779
Application NumberNDA022251
Product Classification
M
Marketing Category
C73594
G
Generic Name
lamotrigine
Product Specifications
Effective DateMarch 31, 2021
FDA Product Classification
lamotrigine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0776
Application NumberNDA022251
Product Classification
M
Marketing Category
C73594
G
Generic Name
lamotrigine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2021
FDA Product Classification
INGREDIENTS (5)
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
LAMOTRIGINEActive
Quantity: 100 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
ETHYLCELLULOSE (100 MPA.S)Inactive
Code: 47MLB0F1MV
Classification: IACT