Lamotrigine

Basic Information

Product Name

Lamotrigine

FDA Product Code

82868-005

Regulatory Information

NDC Product Code

82868-005

Application Number

ANDA077633

Marketing Category

C73584

Effective Date

August 15, 2023

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

LAMOTRIGINE

Quantity: 100 mg in 1 1

Code: U3H27498KS

Class Code: ACTIB

POVIDONE

Code: FZ989GH94E

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

Active Moieties

Code: U3H27498KS

Lamotrigine

Basic Information

Regulatory Information

Company Information

Active Ingredients

MAGNESIUM STEARATE

SODIUM STARCH GLYCOLATE TYPE A POTATO

LACTOSE MONOHYDRATE

POVIDONE

CELLULOSE, MICROCRYSTALLINE

Active Moieties

LAMOTRIGINE