LAMOTRIGINE

Product NDC
68788-7278
11-digit product format
687887278
Labeler code
68788
Product ID
68788-7278_16728ef7-8cec-45e9-a2c9-7599b500b2de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077783
Marketing category
ANDA
Marketing start
2019-01-10
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7278-3EA - Each68788-72788eb8160c-8dab-45ed-9460-9b4186d89de312019-04-11
68788-7278-6EA - Each68788-7278f705654d-2f8b-4884-b0c1-1bc74bd22e1312019-04-11
68788-7278-9EA - Each68788-727861cf9d71-b6d1-4269-8d0f-6bdfacd6891112019-04-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7278-36878872780330 TABLET in 1 BOTTLE (68788-7278-3) 30 tablet2019-01-100000-00-00NoNoCurrent
68788-7278-66878872780660 TABLET in 1 BOTTLE (68788-7278-6) 60 tablet2019-01-100000-00-00NoNoCurrent
68788-7278-96878872780990 TABLET in 1 BOTTLE (68788-7278-9) 90 tablet2019-01-100000-00-00NoNoCurrent