Lamotrigine

Product NDC

42291-353

11-digit product format

422910353

Labeler code

42291

Product ID

42291-353_638d8438-b8c9-f97b-e053-2991aa0a7661

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Lamotrigine

Dosage form

TABLET, CHEWABLE

Route

ORAL

Labeler

AvKARE, Inc.

Application

ANDA076420

Marketing category

ANDA

Marketing start

2017-03-31

Marketing end

0000-00-00

Substance

LAMOTRIGINE

Active strength

5 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