Lamotrigine
These highlights do not include all the information needed to use LAMOTRIGINE TABLETS and LAMOTRIGINE TABLETS FOR ORAL SUSPENSION safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS and LAMOTRIGINE TABLETS FOR ORAL SUSPENSION. LAMOTRIGINE tablets, for oral use LAMOTRIGINE tablets for oral suspension Initial U.S. Approval: 1994
Approved
Approval ID
e849033b-a3bc-408e-88de-7cd1d2660949
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 30, 2023
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
Products 8
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 Code68382-009
Application NumberANDA077633
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lamotrigine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
LAMOTRIGINEActive
Quantity: 150 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Lamotrigine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-007
Application NumberANDA077633
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lamotrigine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (6)
LAMOTRIGINEActive
Quantity: 50 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Lamotrigine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-108
Application NumberANDA078009
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lamotrigine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (9)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
BLACK CURRANTInactive
Code: 9755T40D11
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TRIBASIC CALCIUM PHOSPHATEInactive
Code: 91D9GV0Z28
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LAMOTRIGINEActive
Quantity: 5 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
Lamotrigine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-006
Application NumberANDA077633
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lamotrigine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (6)
LAMOTRIGINEActive
Quantity: 25 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Lamotrigine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-010
Application NumberANDA077633
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lamotrigine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (6)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LAMOTRIGINEActive
Quantity: 200 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
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 Code68382-011
Application NumberANDA077633
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lamotrigine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (6)
LAMOTRIGINEActive
Quantity: 250 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
Lamotrigine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-109
Application NumberANDA078009
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lamotrigine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (9)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LAMOTRIGINEActive
Quantity: 25 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TRIBASIC CALCIUM PHOSPHATEInactive
Code: 91D9GV0Z28
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
BLACK CURRANTInactive
Code: 9755T40D11
Classification: IACT
Lamotrigine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-008
Application NumberANDA077633
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lamotrigine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LAMOTRIGINEActive
Quantity: 100 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT