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 useInitial U.S. Approval: 1994
Approved
Approval ID
11800356-759d-4a8d-8811-e7942a3db6f5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 6, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
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 Code16590-802
Application NumberANDA076388
Product Classification
M
Marketing Category
C73584
G
Generic Name
LAMOTRIGINE
Product Specifications
Route of AdministrationORAL
Effective DateJune 6, 2011
FDA Product Classification
INGREDIENTS (9)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
LAMOTRIGINEActive
Quantity: 100 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LAMOTRIGINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-777
Application NumberANDA076388
Product Classification
M
Marketing Category
C73584
G
Generic Name
LAMOTRIGINE
Product Specifications
Route of AdministrationORAL
Effective DateJune 6, 2011
FDA Product Classification
INGREDIENTS (9)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LAMOTRIGINEActive
Quantity: 200 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
Drug Labeling Information
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 11/9/2010
RECENT MAJOR CHANGES
Warnings and Precautions, Aseptic Meningitis (5.7) 10/2010