Lamotrigine

Product NDC

68462-245

11-digit product format

684620245

Labeler code

68462

Product ID

68462-245_7c5834f5-1006-4617-97a5-9920dec7b847

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Lamotrigine

Dosage form

TABLET

Route

ORAL

Labeler

Glenmark Pharmaceuticals Inc., USA

Application

ANDA090169

Marketing category

ANDA

Marketing start

2012-05-04

Marketing end

0000-00-00

Substance

LAMOTRIGINE

Active strength

150 mg/1

Pharmacologic classes

Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record