FDA.reportPublic FDA data

Lamotrigine

Product NDC
42291-368
11-digit product format
422910368
Labeler code
42291
Product ID
42291-368_51b57ded-2d7d-d540-e063-6394a90a4744
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA079132
Marketing category
ANDA
Marketing start
2013-04-10
Substance
LAMOTRIGINE
Active strength
150 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lamotrigine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAMOTRIGINE150 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
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-368-50Lamotrigine500 in 1 BOTTLETABLET50017
42291-368-60Lamotrigine60 in 1 BOTTLETABLET6017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-368-50EA - Each42291-368e41460e4-54e6-4e57-b24f-b483041fbab912015-03-03
42291-368-60EA - Each42291-368b80f3f46-320b-4e77-93de-45949d868b6b12013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE (LAMOTRIGINE) TABLET [AVKARE, INC.]4
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE (LAMOTRIGINE) TABLET [AVKARE, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE (LAMOTRIGINE) TABLET [AVKARE, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE (LAMOTRIGINE) TABLET [AVKARE, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE (LAMOTRIGINE) TABLET [AVKARE, INC.]4
Starch, CornINACTIVE INGREDIENTO8232NY3SJLAMOTRIGINE (LAMOTRIGINE) TABLET [AVKARE, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-368LAMOTRIGINE TABLET [AVKARE]15Current NDC, Legacy NDC, 2 package rows20220114_fcdb94a8-33be-6375-98ef-6933999d157f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSNfcdb94a8-33be-6375-98ef-6933999d157f17
198428lamoTRIgine 150 MG Oral TabletPSNfcdb94a8-33be-6375-98ef-6933999d157f17
198429lamoTRIgine 200 MG Oral TabletPSNfcdb94a8-33be-6375-98ef-6933999d157f17
282401lamoTRIgine 25 MG Oral TabletPSNfcdb94a8-33be-6375-98ef-6933999d157f17
198427lamotrigine 100 MG Oral TabletSCDfcdb94a8-33be-6375-98ef-6933999d157f17
198428lamotrigine 150 MG Oral TabletSCDfcdb94a8-33be-6375-98ef-6933999d157f17
198429lamotrigine 200 MG Oral TabletSCDfcdb94a8-33be-6375-98ef-6933999d157f17
282401lamotrigine 25 MG Oral TabletSCDfcdb94a8-33be-6375-98ef-6933999d157f17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-368-5042291036850500 TABLET in 1 BOTTLE (42291-368-50) 500 tablet2015-01-280000-00-00NoNoCurrent
42291-368-604229103686060 TABLET in 1 BOTTLE (42291-368-60) 60 tablet2013-04-100000-00-00NoNoCurrent