FDA.reportPublic FDA data

NDC 65862-229-10 - Lamotrigine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
65862-229
Requested NDC
65862-229-10
Package NDCs from labels
65862-229-60, 65862-229-01, 65862-229-99, 65862-229-10, 65862-229-78
Manufacturer
Aurobindo Pharma Limited
Effective date
2026-05-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lamotrigine - Aurobindo Pharma LimitedAurobindo Pharma Limited2026-05-25Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-229-01Lamotrigine100 in 1 BOTTLETABLET10030
65862-229-10Lamotrigine10 in 1 BLISTER PACKTABLET1030
65862-229-60Lamotrigine60 in 1 BOTTLETABLET6030
65862-229-78Lamotrigine10 in 1 CARTONTABLET1030
65862-229-99Lamotrigine1000 in 1 BOTTLETABLET100030

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-229LAMOTRIGINE TABLET [AUROBINDO PHARMA LIMITED]28Current NDC, Legacy NDC, 5 package rows20231218_a9a4309e-fe43-4a26-a30f-c6577d650336.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-229-01EA - Each65862-22950534161-a8df-482f-88b2-e3a2dc33480712012-07-24
65862-229-60EA - Each65862-22973b5cffe-e2c3-4594-a9c2-fcb1644daaa812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [AUROBINDO PHARMA LIMITED]15
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [AUROBINDO PHARMA LIMITED]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET [AUROBINDO PHARMA LIMITED]15
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLAMOTRIGINE TABLET [AUROBINDO PHARMA LIMITED]15
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LAMOTRIGINE TABLET [AUROBINDO PHARMA LIMITED]15
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLAMOTRIGINE TABLET [AUROBINDO PHARMA LIMITED]15
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET [AUROBINDO PHARMA LIMITED]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [AUROBINDO PHARMA LIMITED]15
POVIDONE K30INACTIVE INGREDIENTU725QWY32XLAMOTRIGINE TABLET [AUROBINDO PHARMA LIMITED]15
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMOTRIGINE TABLET [AUROBINDO PHARMA LIMITED]15

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamotrigineLAMOTRIGINENorthstar Rx LLC.aabc64fe-1f17-4140-81f2-7d4506db6c8b2025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
lamotrigineLAMOTRIGINE EXTENDED-RELEASEYiling Pharmaceutical, Inc.f7de11a5-5357-4753-b1ac-b15123b500282025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEA-S Medication Solutions84277e2c-370c-4510-92bc-ef33a4a0f5082025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLC9e5c2d76-47a6-4a57-b23c-2398b307380c2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEAjanta Pharma USA Inc.9dfb5f87-0150-4c26-a89f-34f1ab3895002025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEDr.Reddy's Laboratories Limiteda69542ea-5b6f-15c1-9e7a-90ac839971d32025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINENorthStar Rx LLC9ab07d6b-ae4a-a310-5572-b266676cd29e2025-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEAdvagen Pharma Limited4ca9d713-ab63-48bf-9386-29301a842e602025-11-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEZydus Pharmaceuticals USA Inc.e849033b-a3bc-408e-88de-7cd1d26609492025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEZydus Pharmaceuticals USA Inc.eb436371-d188-4803-a864-07b90c357e572025-11-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LAMICTALLAMOTRIGINEGlaxoSmithKline LLCd7e3572d-56fe-4727-2bb4-013ccca226782025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
LAMICTAL XRLAMOTRIGINEGlaxoSmithKline LLC3e2c9a35-6a39-41d7-ad84-3c0bb8894b092025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEZydus Lifesciences Limited0f2f7421-56d4-45d0-9d2d-dc1edaede0392025-10-04Exact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEBryant Ranch Prepack8e1e4fa8-881c-4618-88f6-018ab15db44d2025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198428
unii: U3H27498KS
LamotrigineLAMOTRIGINEBryant Ranch Prepack812bc0d8-bb31-4fb1-9f4a-f8c17cbc769c2025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEBryant Ranch Prepack53774022-ea0c-42a9-a720-dc755c77b8512025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198427
unii: U3H27498KS
LamotrigineLAMOTRIGINECoupler LLC3dfdcc2d-b7c5-7abf-e063-6394a90a24a62025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078956
rxcui: 282401
unii: U3H27498KS
LamotrigineLAMOTRIGINEBryant Ranch Prepackd33c4293-347c-49a1-9d98-f291c3dab6da2025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198428
unii: U3H27498KS
LamotrigineLAMOTRIGINEJubilant Cadista Pharmacuticals Inc.0b0f0209-edbd-46f3-9bed-762cbea0d7372025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEBryant Ranch Prepack2cf33586-e48a-4b4e-b14b-33de2be63c1d2025-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
unii: U3H27498KS

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.