FDA.reportPublic FDA data

Lamotrigine

Product NDC
21695-227
11-digit product format
216950227
Labeler code
21695
Product ID
21695-227_7332e0ea-fbd0-43fb-8d1e-f7068504c61d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA078525
Marketing category
NDA
Marketing start
2009-01-27
Marketing end
0000-00-00
Substance
LAMOTRIGINE
Active strength
25 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
21695-227-602019-09-24C16284748780-1934fe258-4791-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use LAMOTRIGINE safely and effectively. See full prescribing information for LAMOTRIGINE. LAMOTRIGINE Tablets Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-227-60Lamotrigine60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-227-60EA - Each21695-227b08baca3-8122-48e7-98b5-a7f172505b1e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LamotrigineACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
LamotrigineACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
Aluminum OxideINACTIVE INGREDIENTLMI26O6933LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
Croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
crospovidoneINACTIVE INGREDIENT68401960MKLAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
FD&C Blue NO. 2INACTIVE INGREDIENTL06K8R7DQKLAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTLAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
povidoneINACTIVE INGREDIENTFZ989GH94ELAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-227LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20120118_7332e0ea-fbd0-43fb-8d1e-f7068504c61d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSN7332e0ea-fbd0-43fb-8d1e-f7068504c61d1
198428lamoTRIgine 150 MG Oral TabletPSN7332e0ea-fbd0-43fb-8d1e-f7068504c61d1
198429lamoTRIgine 200 MG Oral TabletPSN7332e0ea-fbd0-43fb-8d1e-f7068504c61d1
282401lamoTRIgine 25 MG Oral TabletPSN7332e0ea-fbd0-43fb-8d1e-f7068504c61d1
198427lamotrigine 100 MG Oral TabletSCD7332e0ea-fbd0-43fb-8d1e-f7068504c61d1
198428lamotrigine 150 MG Oral TabletSCD7332e0ea-fbd0-43fb-8d1e-f7068504c61d1
198429lamotrigine 200 MG Oral TabletSCD7332e0ea-fbd0-43fb-8d1e-f7068504c61d1
282401lamotrigine 25 MG Oral TabletSCD7332e0ea-fbd0-43fb-8d1e-f7068504c61d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-227-602169502276060 in 1 BOTTLEHistorical