Lamotrigine

Product NDC

50436-3996

11-digit product format

504363996

Labeler code

50436

Product ID

50436-3996_c602621b-13e0-44e4-a644-3b8ee9fb92ed

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Lamotrigine

Dosage form

TABLET

Route

ORAL

Labeler

Unit Dose Services

Application

ANDA079132

Marketing category

ANDA

Marketing start

2009-01-27

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

2019-12-31

Current FDA listing

Historical FDA.report record