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 Tablets LAMICTAL ODT (lamotrigine) Orally Disintegrating TabletsInitial U.S. Approval: 1994
Approved
Approval ID
17a20462-d9d2-43ac-bcad-603e8cc76e3b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 2
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 Code21695-224
Application NumberNDA020241
Product Classification
M
Marketing Category
C73594
G
Generic Name
lamotrigine
Product Specifications
Route of AdministrationORAL
Effective DateApril 1, 2009
FDA Product Classification
INGREDIENTS (7)
LAMOTRIGINEActive
Quantity: 150 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
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 Code21695-223
Application NumberNDA020241
Product Classification
M
Marketing Category
C73594
G
Generic Name
lamotrigine
Product Specifications
Route of AdministrationORAL
Effective DateApril 1, 2009
FDA Product Classification
INGREDIENTS (7)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
LAMOTRIGINEActive
Quantity: 100 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT