FDA.reportPublic FDA data

Lamotrigine

Product NDC
63629-4697
11-digit product format
636294697
Labeler code
63629
Product ID
63629-4697_e4c53c49-1846-4473-a793-6c9d23b70260
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA079132
Marketing category
ANDA
Marketing start
2009-01-27
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
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
LAMOTRIGINE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3H27498KS
Rxcui198428

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
63629-4697-12025-09-04C16284748780-19855d018-e42f-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE tablets, for oral use Initial U.S. Approval: 1994
63629-4697-22025-09-04C16284748780-19855d018-e42f-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE tablets, for oral use Initial U.S. Approval: 1994
63629-4697-32025-09-04C16284748780-19855d018-e42f-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE tablets, for oral use Initial U.S. Approval: 1994
63629-4697-42025-09-04C16284748780-19855d018-e42f-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE tablets, for oral use Initial U.S. Approval: 1994
63629-4697-52025-09-04C16284748780-19855d018-e42f-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE tablets, for oral use Initial U.S. Approval: 1994
63629-4697-12024-01-30C16284748780-19855d018-e42f-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE tablets, for oral use Initial U.S. Approval: 1994
63629-4697-22024-01-30C16284748780-19855d018-e42f-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE tablets, for oral use Initial U.S. Approval: 1994
63629-4697-32024-01-30C16284748780-19855d018-e42f-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE tablets, for oral use Initial U.S. Approval: 1994
63629-4697-42024-01-30C16284748780-19855d018-e42f-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE tablets, for oral use Initial U.S. Approval: 1994
63629-4697-52024-01-30C16284748780-19855d018-e42f-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE tablets, for oral use Initial U.S. Approval: 1994
63629-4697-12022-02-16C16284748780-19855d018-e42f-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE tablets, for oral use Initial U.S. Approval: 1994
63629-4697-12019-11-27C16284748780-19855d018-e42f-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE tablets, for oral use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4697-1Lamotrigine60 in 1 BOTTLETABLET601002
63629-4697-2Lamotrigine30 in 1 BOTTLETABLET301002
63629-4697-3Lamotrigine90 in 1 BOTTLETABLET901002
63629-4697-4Lamotrigine120 in 1 BOTTLETABLET1201002
63629-4697-5Lamotrigine180 in 1 BOTTLETABLET1801002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4697-1EA - Each63629-4697faf98bdc-94fa-4e55-a92d-292cadd3116412015-10-02
63629-4697-2EA - Each63629-4697f0311ea0-3383-4f16-9c58-3e91dca02c5612022-03-09
63629-4697-3EA - Each63629-46975fff2e34-6af2-4ee0-bbe0-319bacc07df912022-03-09
63629-4697-4EA - Each63629-4697b2b8e27e-59ac-4175-951e-38ccc22ffb8e12022-03-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE (LAMOTRIGINE) TABLET [BRYANT RANCH PREPACK]1000
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE (LAMOTRIGINE) TABLET [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE (LAMOTRIGINE) TABLET [BRYANT RANCH PREPACK]1000
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE (LAMOTRIGINE) TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE (LAMOTRIGINE) TABLET [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLAMOTRIGINE (LAMOTRIGINE) TABLET [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4697LAMOTRIGINE (LAMOTRIGINE) TABLET [BRYANT RANCH PREPACK]1001Current NDC, Legacy NDC, 5 package rows20220217_d33c4293-347c-49a1-9d98-f291c3dab6da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198428lamoTRIgine 150 MG Oral TabletPSNd33c4293-347c-49a1-9d98-f291c3dab6da1002
198428lamotrigine 150 MG Oral TabletSCDd33c4293-347c-49a1-9d98-f291c3dab6da1002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-4697-16362946970160 TABLET in 1 BOTTLE (63629-4697-1) 60 tablet2012-04-050000-00-00NoNoCurrent
63629-4697-26362946970230 TABLET in 1 BOTTLE (63629-4697-2) 30 tablet2016-11-020000-00-00NoNoCurrent
63629-4697-36362946970390 TABLET in 1 BOTTLE (63629-4697-3) 90 tablet2017-09-210000-00-00NoNoCurrent
63629-4697-463629469704120 TABLET in 1 BOTTLE (63629-4697-4) 120 tablet2022-02-150000-00-00NoNoCurrent
63629-4697-563629469705180 TABLET in 1 BOTTLE (63629-4697-5) 180 tablet2022-02-150000-00-00NoNoCurrent