Lamotrigine
These highlights do not include all the information needed to use LAMOTRIGINE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE ORALLY DISINTEGRATING TABLETS. LAMOTRIGINE orally disintegrating tablets, for oral use Initial U.S. Approval: 1994
Approved
Approval ID
54ea1ec3-876b-4d3a-a92b-1a6d70951de0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 3, 2022
Manufacturers
FDA
Dr. Reddy’s Laboratories Inc.
DUNS: 802315887
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lamotrigine
PRODUCT DETAILS
NDC Product Code43598-550
Application NumberANDA206382
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 3, 2022
Generic NameLamotrigine
INGREDIENTS (12)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIH
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
KOLLIDON SRInactive
Code: S34RY76LK6
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TRICALCIUM PHOSPHATEInactive
Code: K4C08XP666
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
LAMOTRIGINEActive
Quantity: 25 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
Lamotrigine
PRODUCT DETAILS
NDC Product Code43598-551
Application NumberANDA206382
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 3, 2022
Generic NameLamotrigine
INGREDIENTS (12)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIH
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
KOLLIDON SRInactive
Code: S34RY76LK6
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TRICALCIUM PHOSPHATEInactive
Code: K4C08XP666
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LAMOTRIGINEActive
Quantity: 50 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
Lamotrigine
PRODUCT DETAILS
NDC Product Code43598-552
Application NumberANDA206382
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 3, 2022
Generic NameLamotrigine
INGREDIENTS (12)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
KOLLIDON SRInactive
Code: S34RY76LK6
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIH
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TRICALCIUM PHOSPHATEInactive
Code: K4C08XP666
Classification: IACT
LAMOTRIGINEActive
Quantity: 100 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
Lamotrigine
PRODUCT DETAILS
NDC Product Code43598-553
Application NumberANDA206382
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 3, 2022
Generic NameLamotrigine
INGREDIENTS (12)
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIH
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
KOLLIDON SRInactive
Code: S34RY76LK6
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
TRICALCIUM PHOSPHATEInactive
Code: K4C08XP666
Classification: IACT
LAMOTRIGINEActive
Quantity: 200 mg in 1 1
Code: U3H27498KS
Classification: ACTIB