Lamotrigine

Product NDC

59115-065

11-digit product format

591150065

Labeler code

59115

Product ID

59115-065_9d63c23d-d4d7-4abc-93a2-f9269abdad34

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Lamotrigine

Dosage form

TABLET

Route

ORAL

Labeler

Hikma Pharmaceutical

Application

ANDA078134

Marketing category

ANDA

Marketing start

2011-04-19

Marketing end

0000-00-00

Substance

LAMOTRIGINE

Active strength

25 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