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 USP, for oral use Initial U.S. Approval: 1994
Approved
Approval ID
474fb321-575c-4b97-9dbe-080061652ee4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 14, 2021
Manufacturers
FDA
OWP Pharmaceuticals, Inc.
DUNS: 079392532
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 Code69102-137
Application NumberANDA078947
Product Classification
M
Marketing Category
C73584
G
Generic Name
LAMOTRIGINE
Product Specifications
Effective DateMay 14, 2021
FDA Product Classification
LAMOTRIGINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69102-639
Application NumberANDA078947
Product Classification
M
Marketing Category
C73584
G
Generic Name
LAMOTRIGINE
Product Specifications
Route of AdministrationORAL
Effective DateMay 14, 2021
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LAMOTRIGINEActive
Quantity: 25 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
LAMOTRIGINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69102-359
Application NumberANDA078947
Product Classification
M
Marketing Category
C73584
G
Generic Name
LAMOTRIGINE
Product Specifications
Effective DateMay 14, 2021
FDA Product Classification