FDA.reportPublic FDA data

NDC 51672-4130-01 - 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
51672-4130
Requested NDC
51672-4130-01
Package NDCs from labels
51672-4130-6, 51672-4130-4, 51672-4130-1, 51672-4130-3, 51672-4130-0, 51672-4130-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.
Effective date
2026-06-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LamotrigineSun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.2026-06-03HUMAN PRESCRIPTION DRUG LABEL
Lamotrigine - REMEDYREPACK INC.REMEDYREPACK INC.2025-06-27HUMAN PRESCRIPTION DRUG LABEL
Lamotrigine - Preferred Pharmaeuticals Inc.Preferred Pharmaeuticals Inc.2024-06-05HUMAN PRESCRIPTION DRUG LABEL
Lamotrigine - ST. MARY'S MEDICAL PARK PHARMACYST. MARY'S MEDICAL PARK PHARMACY2022-07-27HUMAN PRESCRIPTION DRUG LABEL
Lamotrigine - A-S Medication SolutionsA-S Medication Solutions2018-07-26HUMAN PRESCRIPTION DRUG LABEL
Lamotrigine - A-S Medication SolutionsA-S Medication Solutions2018-06-12HUMAN PRESCRIPTION DRUG LABEL
Lamotrigine - State of Florida DOH Central PharmacyState of Florida DOH Central Pharmacy2015-01-03HUMAN PRESCRIPTION DRUG LABEL
Lamotrigine - Rebel Distributors CorpRebel Distributors Corp2010-09-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4130-0Lamotrigine10 in 1 BLISTER PACKTABLET1021
51672-4130-0Lamotrigine10 in 1 CARTONTABLET1021
51672-4130-1Lamotrigine100 in 1 BOTTLETABLET10021
51672-4130-3Lamotrigine1000 in 1 BOTTLETABLET100021
51672-4130-4Lamotrigine60 in 1 BOTTLETABLET6021
51672-4130-6Lamotrigine30 in 1 BOTTLETABLET3021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4130LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]15Current NDC, Legacy NDC, 6 package rows20230517_b829f9b2-f0ac-408a-a6f4-18b72150227d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4130-1EA - Each51672-4130b1138f13-a1a8-4495-a8a5-2c4d49568df512012-07-24
51672-4130-3EA - Each51672-413033c9112c-59c4-4d89-834e-19e4d2ec823312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LamotrigineACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]8
LamotrigineACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]8
Aluminum OxideINACTIVE INGREDIENTLMI26O6933LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]8
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]8
Croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]8
crospovidoneINACTIVE INGREDIENT68401960MKLAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]8
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKLAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]8
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]8
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTLAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]8
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]8
magnesium stearateINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]8
povidonesINACTIVE INGREDIENTFZ989GH94ELAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]8
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LamotrigineACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
LamotrigineACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
Aluminum OxideINACTIVE INGREDIENTLMI26O6933LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
Croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]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
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
magnesium stearateINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
povidoneINACTIVE INGREDIENTFZ989GH94ELAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ELAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

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 7 of 13 · 255 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
CONSTIPATIONMAGNESIA CARBONICA, MAGNESIA MURIATICA, AESCULUS HIPPOCASTANUM, ALUMEN, ALUMINA, BRYONIA ALBA, NUX VOMICA, SILICEANatural Creations, Inc.d2e24f5a-747b-4d62-bbdf-16c0e43becdb2025-11-21WarningsExact identifier
unii: LMI26O6933
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
Berberis ViscumBERBERIS VISCUMUriel Pharmacy Inc.30abbbd6-1657-4959-9f07-85ddf45f11192025-11-14WarningsExact identifier
unii: LMI26O6933
ALUMIZENGARLIC, AVENA SATIVA FLOWERING TOP, BERBERIS VULGARIS ROOT BARK, ARCTIUM LAPPA ROOT, PHYTOLACCA AMERICANA ROOT, SOLIDAGO VIRGAUREA FLOWERING TOP, ALUMINUM OXIDE, SILVER NITRATE, BARIUM CARBONATE, BERYLLIUM, CADMIUM, COPPER, HYDROFLUORIC ACID, INDIUM, IODINE, LITHIUM CARBONATE, MERCURIUS SOLUBILIS, NICKEL CARBONATE HYDROXIDE TETRAHYDRATE, NITROUS OXIDE, LEAD, SELENIUM, STRONTIUM CARBONATE, TITANIUM, ARSENIC TRIOXIDE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED.Natural Creations, Inc.4760ab09-1141-4944-b840-804ae6d86d2d2025-11-13WarningsExact identifier
unii: LMI26O6933
LamotrigineLAMOTRIGINEZydus Pharmaceuticals USA Inc.eb436371-d188-4803-a864-07b90c357e572025-11-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: FZ989GH94E
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: FZ989GH94E
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
unii: FZ989GH94E
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
unii: FZ989GH94E
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
ColostatRHAMNUS PURSHIANA, SPIGELIA ANTHELMIA, TARAXACUM OFFICINALE, CAJUPUTUM, HYDRASTIS CANADENSIS, ALUMINA, CINA, CINCHONA OFFICINALIS, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, MANDRAGORA OFFICINARUM, NUX VOMICAEnergique, Inc.89c86e7b-304c-43a6-81e7-373d95c9fac12025-10-06WarningsExact identifier
unii: LMI26O6933
LamotrigineLAMOTRIGINEZydus Lifesciences Limited0f2f7421-56d4-45d0-9d2d-dc1edaede0392025-10-04Exact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
Jet LagECHINACEA, ALUMINA, ARALIA QUINQUEFOLIA, ARGENTUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IODIUM, KALI CARBONICUM, KALI IODATUM, LYCOPODIUM CLAVATUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOXICODENDRON, SABAL SERRULATA, THYROIDINUM.Newton Laboratories, Inc.9c21c935-4ebc-1efd-e053-2995a90aa1562025-09-18WarningsExact identifier
unii: LMI26O6933

Reported adverse events (FAERS/openFDA)#

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