LAMOTRIGINE

Product NDC
43063-202
11-digit product format
430630202
Labeler code
43063
Product ID
43063-202_dd408dab-1c46-d43f-e053-2995a90a7351
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LAMOTRIGINE
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078947
Marketing category
ANDA
Marketing start
2009-01-27
Marketing end
0000-00-00
Substance
LAMOTRIGINE
Active strength
200 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-202-30EA - Each43063-2027ab7fc08-4d16-4fcd-87a9-0cdcb04aea1712012-07-24
43063-202-60EA - Each43063-202648d9857-a125-4442-8d86-70269ef1c8ad12012-07-24
43063-202-90EA - Each43063-2024964879e-d1c8-4eeb-9964-66e8677713e612012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-202-304306302023030 TABLET in 1 BOTTLE, PLASTIC (43063-202-30) 30 tablet2010-08-130000-00-00NoNoCurrent
43063-202-604306302026060 TABLET in 1 BOTTLE, PLASTIC (43063-202-60) 60 tablet2010-08-130000-00-00NoNoCurrent
43063-202-904306302029090 TABLET in 1 BOTTLE, PLASTIC (43063-202-90) 90 tablet2010-08-130000-00-00NoNoCurrent