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Lamotrigine

Lamotrigine Tablets, USP 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 use Rx Only Initial U.S. Approval: 1994

Approved
Approval ID

fcdb94a8-33be-6375-98ef-6933999d157f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 13, 2022

Manufacturers
FDA

AvKARE

DUNS: 796560394

Products 4

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 Code42291-369
Application NumberANDA079132
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lamotrigine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 13, 2022
FDA Product Classification

INGREDIENTS (5)

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LAMOTRIGINEActive
Quantity: 200 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT

Lamotrigine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42291-367
Application NumberANDA079132
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lamotrigine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 13, 2022
FDA Product Classification

INGREDIENTS (5)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LAMOTRIGINEActive
Quantity: 100 mg in 1 1
Code: U3H27498KS
Classification: ACTIB

Lamotrigine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42291-368
Application NumberANDA079132
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lamotrigine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 13, 2022
FDA Product Classification

INGREDIENTS (5)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
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

Lamotrigine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42291-366
Application NumberANDA079132
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lamotrigine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 13, 2022
FDA Product Classification

INGREDIENTS (5)

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LAMOTRIGINEActive
Quantity: 25 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT

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