LAMOTRIGINE

Product NDC
61919-777
11-digit product format
619190777
Labeler code
61919
Product ID
61919-777_8c4ac1dc-3faa-4180-a9bf-913ccc1d283c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LAMOTRIGINE
Dosage form
TABLET
Route
ORAL
Labeler
Direct RX
Application
ANDA090170
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
LAMOTRIGINE
Active strength
200 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-777-302020-01-31C16284748780-19d75b9d0-1af5-f424-e053-dadaa90a57ceLAMOTRIGINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-777-30LAMOTRIGINE30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-777-30EA - Each61919-777d12bbd52-9b58-47b9-9286-862f18bc740212016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [DIRECT RX]1
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET [DIRECT RX]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLAMOTRIGINE TABLET [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [DIRECT RX]1
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQLAMOTRIGINE TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMOTRIGINE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-777LAMOTRIGINE TABLET [DIRECT RX]1Legacy NDC, 1 package rows20150702_0b9da408-7857-4ff8-86f9-ae56bfd0fe38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198429lamoTRIgine 200 MG Oral TabletPSN0b9da408-7857-4ff8-86f9-ae56bfd0fe381
198429lamotrigine 200 MG Oral TabletSCD0b9da408-7857-4ff8-86f9-ae56bfd0fe381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-777-306191907773030 in 1 BOTTLEHistorical