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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 LAMICTAL (lamotrigine) Chewable Dispersible TabletsLAMICTAL ODT (lamotrigine) Orally Disintegrating TabletsInitial U.S. Approval: 1994

Approved
Approval ID

22a9788c-5a9b-411e-844e-4a0b12d1d095

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 21, 2011

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 3

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 Code54868-4675
Application NumberNDA020241
Product Classification
M
Marketing Category
C73594
G
Generic Name
lamotrigine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2011
FDA Product Classification

INGREDIENTS (7)

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LAMOTRIGINEActive
Quantity: 100 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT

lamotrigine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-4916
Application NumberNDA020241
Product Classification
M
Marketing Category
C73594
G
Generic Name
lamotrigine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2011
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
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
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 Code54868-4673
Application NumberNDA020241
Product Classification
M
Marketing Category
C73594
G
Generic Name
lamotrigine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2011
FDA Product Classification

INGREDIENTS (6)

LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LAMOTRIGINEActive
Quantity: 25 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT

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LAMICTAL - FDA Drug Approval Details