Lamotrigine

Product NDC

0143-9965

11-digit product format

001439965

Labeler code

0143

Product ID

0143-9965_d08400cf-c8da-47a6-85a0-7235db7c74c3

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Lamotrigine

Dosage form

TABLET

Route

ORAL

Labeler

Hikma Pharmaceuticals USA Inc.

Application

ANDA078134

Marketing category

ANDA

Marketing start

2011-04-19

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

2020-12-31

Current FDA listing

Historical FDA.report record