Lamotrigine

Product NDC
55111-221
11-digit product format
551110221
Labeler code
55111
Product ID
55111-221_b59e510e-d6aa-6f6b-53ef-3152aeedced7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Dr.Reddy's Laboratories Limited
Application
ANDA076708
Marketing category
ANDA
Marketing start
2009-01-29
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, 198428, 198429, 282401

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
14a9502b-3d70-0496-a7e1-b16edaa005b8Product name520250423
16d731ed-ff3e-e9a1-3e3e-1ef6b6be40a0Product name720250401
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-221-01Lamotrigine100 in 1 BOTTLETABLET10011
55111-221-05Lamotrigine500 in 1 BOTTLETABLET50011
55111-221-30Lamotrigine30 in 1 BOTTLETABLET3011
55111-221-60Lamotrigine60 in 1 BOTTLETABLET6011
55111-221-78Lamotrigine10 in 1 CARTONTABLET1011
55111-221-79Lamotrigine10 in 1 BLISTER PACKTABLET1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-221-01EA - Each55111-221a62522b4-7c51-4592-9529-3e11ad0420f812012-07-24
55111-221-05EA - Each55111-221f0476f37-8011-483e-891a-fee540fe326312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [DR.REDDY'S LABORATORIES LIMITED]9
LamotrigineACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [DR.REDDY'S LABORATORIES LIMITED]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-221LAMOTRIGINE TABLET [DR.REDDY'S LABORATORIES LIMITED]11Current NDC, Legacy NDC, 6 package rows20241222_44670496-41ea-36a1-c435-32e359766a74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSN44670496-41ea-36a1-c435-32e359766a7411
198428lamoTRIgine 150 MG Oral TabletPSN44670496-41ea-36a1-c435-32e359766a7411
198429lamoTRIgine 200 MG Oral TabletPSN44670496-41ea-36a1-c435-32e359766a7411
282401lamoTRIgine 25 MG Oral TabletPSN44670496-41ea-36a1-c435-32e359766a7411
198427lamotrigine 100 MG Oral TabletSCD44670496-41ea-36a1-c435-32e359766a7411
198428lamotrigine 150 MG Oral TabletSCD44670496-41ea-36a1-c435-32e359766a7411
198429lamotrigine 200 MG Oral TabletSCD44670496-41ea-36a1-c435-32e359766a7411
282401lamotrigine 25 MG Oral TabletSCD44670496-41ea-36a1-c435-32e359766a7411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-221-0155111022101100 TABLET in 1 BOTTLE (55111-221-01) 100 tablet2009-01-290000-00-00NoNoCurrent
55111-221-0555111022105500 TABLET in 1 BOTTLE (55111-221-05) 500 tablet2009-01-290000-00-00NoNoCurrent
55111-221-305511102213030 TABLET in 1 BOTTLE (55111-221-30) 30 tablet2009-01-290000-00-00NoNoCurrent
55111-221-605511102216060 TABLET in 1 BOTTLE (55111-221-60) 60 tablet2009-01-290000-00-00NoNoCurrent
55111-221-785511102217810 BLISTER PACK in 1 CARTON (55111-221-78) / 10 TABLET in 1 BLISTER PACK (55111-221-79) 10 blister pack2009-01-290000-00-00NoNoCurrent
55111-221-795511102217910 in 1 BLISTER PACKHistorical