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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

35aa48a2-2ce6-4a6e-bf5a-1bc6111d1234

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 11, 2023

Manufacturers
FDA

American Health Packaging

DUNS: 929561009

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 Code68084-319
Application NumberANDA077633
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lamotrigine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2023
FDA Product Classification

INGREDIENTS (6)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
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 Code68084-318
Application NumberANDA077633
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lamotrigine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2023
FDA Product Classification

INGREDIENTS (6)

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LAMOTRIGINEActive
Quantity: 25 mg in 1 1
Code: U3H27498KS
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

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Lamotrigine - FDA Drug Approval Details