Lamotrigine

Product NDC
71205-245
11-digit product format
712050245
Labeler code
71205
Product ID
71205-245_df5002ba-15f4-4e47-8d2e-1ce041c26944
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090170
Marketing category
ANDA
Marketing start
2011-11-01
Substance
LAMOTRIGINE
Active strength
100 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lamotrigine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAMOTRIGINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3H27498KS
Rxcui198427

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
14a9502b-3d70-0496-a7e1-b16edaa005b8Product name520250423
16d731ed-ff3e-e9a1-3e3e-1ef6b6be40a0Product name720250401
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-245-30Lamotrigine30 in 1 BOTTLE, PLASTICTABLET304
71205-245-60Lamotrigine60 in 1 BOTTLE, PLASTICTABLET604
71205-245-90Lamotrigine90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-245-30EA - Each71205-2450aeda5a8-c82f-4a52-9540-f91e16f2aefd12019-06-19
71205-245-90EA - Each71205-245f4de7b13-6d44-4685-9fec-e63a0f15b21212026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-245LAMOTRIGINE TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20220528_52273d60-3f27-4846-bf40-014ebcf09417.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSN52273d60-3f27-4846-bf40-014ebcf094174
198427lamotrigine 100 MG Oral TabletSCD52273d60-3f27-4846-bf40-014ebcf094174

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-245-307120502453030 TABLET in 1 BOTTLE, PLASTIC (71205-245-30) 30 tablet2019-04-010000-00-00NoNoCurrent
71205-245-607120502456060 TABLET in 1 BOTTLE, PLASTIC (71205-245-60) 60 tablet2019-04-010000-00-00NoNoCurrent
71205-245-907120502459090 TABLET in 1 BOTTLE, PLASTIC (71205-245-90) 90 tablet2019-04-010000-00-00NoNoCurrent