Lamotrigine

Product NDC

0615-7545

11-digit product format

006157545

Labeler code

0615

Product ID

0615-7545_6bf9a99a-7d36-4e31-b6b5-5ea65b5e942e

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Lamotrigine

Dosage form

TABLET

Route

ORAL

Labeler

NCS HealthCare of KY, Inc dba Vangard Labs

Application

ANDA076388

Marketing category

ANDA

Marketing start

2008-07-22

Marketing end

0000-00-00

Substance

LAMOTRIGINE

Active strength

100 mg/1

Pharmacologic classes

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

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record