FDA.reportPublic FDA data

LAMICTAL

Product NDC
21695-223
11-digit product format
216950223
Labeler code
21695
Product ID
21695-223_17a20462-d9d2-43ac-bcad-603e8cc76e3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA020241
Marketing category
NDA
Marketing start
1995-01-17
Marketing end
0000-00-00
Substance
LAMOTRIGINE
Active strength
100 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
21695-223-302019-09-24C16284748780-1934fe258-4731-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use LAMICTAL safely and effectively. See full prescribing information for LAMICTAL. LAMICTAL (lamotrigine) Tablets LAMICTAL (lamotrigine) Chewable Dispersible Tablets LAMICTAL ODT (lamotrigine) Orally Disintegrating Tablets Initial U.S. Approval: 1994
21695-223-602019-09-24C16284748780-1934fe258-4731-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use LAMICTAL safely and effectively. See full prescribing information for LAMICTAL. LAMICTAL (lamotrigine) Tablets LAMICTAL (lamotrigine) Chewable Dispersible Tablets LAMICTAL ODT (lamotrigine) Orally Disintegrating Tablets Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-223-30LAMICTAL30 in 1 BOTTLETABLET301
21695-223-60LAMICTAL60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-223-30EA - Each21695-2233de61e59-ef08-4401-90f8-e36e85c2b59b12012-07-24
21695-223-60EA - Each21695-2239d7eff14-c524-4b3e-b817-dfbce8967b7e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMICTAL (LAMOTRIGINE) TABLET [REBEL DISTRIBUTORS CORP]1
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMICTAL (LAMOTRIGINE) TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMICTAL (LAMOTRIGINE) TABLET [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LAMICTAL (LAMOTRIGINE) TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLAMICTAL (LAMOTRIGINE) TABLET [REBEL DISTRIBUTORS CORP]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLAMICTAL (LAMOTRIGINE) TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMICTAL (LAMOTRIGINE) TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ELAMICTAL (LAMOTRIGINE) TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMICTAL (LAMOTRIGINE) TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-223LAMICTAL (LAMOTRIGINE) TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110104_17a20462-d9d2-43ac-bcad-603e8cc76e3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
105018LaMICtal 100 MG Oral TabletPSN17a20462-d9d2-43ac-bcad-603e8cc76e3b1
206201LaMICtal 150 MG Oral TabletPSN17a20462-d9d2-43ac-bcad-603e8cc76e3b1
198427lamoTRIgine 100 MG Oral TabletPSN17a20462-d9d2-43ac-bcad-603e8cc76e3b1
198428lamoTRIgine 150 MG Oral TabletPSN17a20462-d9d2-43ac-bcad-603e8cc76e3b1
105018lamotrigine 100 MG Oral Tablet [Lamictal]SBD17a20462-d9d2-43ac-bcad-603e8cc76e3b1
206201lamotrigine 150 MG Oral Tablet [Lamictal]SBD17a20462-d9d2-43ac-bcad-603e8cc76e3b1
198427lamotrigine 100 MG Oral TabletSCD17a20462-d9d2-43ac-bcad-603e8cc76e3b1
198428lamotrigine 150 MG Oral TabletSCD17a20462-d9d2-43ac-bcad-603e8cc76e3b1
105018Lamictal 100 MG Oral TabletSY17a20462-d9d2-43ac-bcad-603e8cc76e3b1
206201Lamictal 150 MG Oral TabletSY17a20462-d9d2-43ac-bcad-603e8cc76e3b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-223-302169502233030 in 1 BOTTLEHistorical
21695-223-602169502236060 in 1 BOTTLEHistorical