Lamotrigine

Product NDC
60760-543
11-digit product format
607600543
Labeler code
60760
Product ID
60760-543_e55a9e50-61e8-2b3f-e053-2995a90a4b74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA078525
Marketing category
ANDA
Marketing start
2022-07-27
Marketing end
0000-00-00
Substance
LAMOTRIGINE
Active strength
25 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
60760-543-30EA - Each60760-5437a05594e-eb67-4d40-aa35-c4aa91056fe612022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-543LAMOTRIGINE TABLET [ST. MARY'S MEDICAL PARK PHARMACY]1Legacy NDC20220805_e55a986a-217f-678e-e053-2a95a90aa779.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-543-306076005433030 TABLET in 1 BOTTLE, PLASTIC (60760-543-30) 30 tablet2022-07-270000-00-00NoNoCurrent