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 13 of 13 · 255 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GUNA BOWEL PLUSACTIVATED CHARCOAL - ALOE - ALUMINUM OXIDE - BRYONIA ALBA ROOT - CHELIDONIUM MAJUS - COLLINSONIA - FRANGULA ALNUS BARK - LYCOPODIUM CLAVATUM SPORE - POTASSIUM CARBONATE- RHUBARB - STRYCHNOS NUX VOMICA SEED - SILYBUM MARIANUM SEED - SKATOLE - SODIUM CARBONATE - SUS SCROFA PANCREAS - TARAXACUM OFFICINALE - THIAMINE -Guna spab3aa4fd3-c87a-ccd2-e053-2995a90a46a92021-01-17WarningsExact identifier
unii: LMI26O6933
Post - VaccinationINFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUMNewton Laboratories, Inc.997474d5-4dc4-6104-e053-2995a90a03f12020-12-07WarningsExact identifier
unii: LMI26O6933
ConstipationABIES NIG., AESCULUS HIPP., ALOE, ALUMINA, BRYONIA, CARBO VEG., CHELIDONIUM MAJUS, COLLINSONIA , GRAPHITES, HYDRASTIS, KALI CARB., LYCOPODIUM, MAG. MUR., MEZEREUM, NUX VOM., PODOPH. PELT., RHAMNUS PURSHIANA, SANICULA, SELENIUM, SEPIA, SILICEA, TABACUM, VERATRUM ALB., ZINC.MET., ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA, TARAXACUMNewton Laboratories, Inc.90807700-3099-850c-e053-2995a90ada552020-11-24WarningsExact identifier
unii: LMI26O6933
ConstipationABIES NIG., AESCULUS HIPP., ALOE, ALUMINA, BRYONIA, CARBO VEG., CHELIDONIUM MAJUS, COLLINSONIA , GRAPHITES, HYDRASTIS, KALI CARB., LYCOPODIUM, MAG. MUR., MEZEREUM, NUX VOM., PODOPH. PELT., RHAMNUS PURSHIANA, SANICULA, SELENIUM, SEPIA, SILICEA, TABACUM, VERATRUM ALB., ZINC.MET., ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA, TARAXACUMNewton Laboratories, Inc.90804a94-1e67-3ab3-e053-2a95a90aafbe2020-11-24WarningsExact identifier
unii: LMI26O6933
Post - VaccinationINFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUMNewton Laboratories, Inc.9042b7ad-15ed-0e81-e053-2a95a90afe282020-11-23WarningsExact identifier
unii: LMI26O6933
Post-VaccinationINFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUMNewton Laboratories, Inc.90bb15e5-3d9d-e2e2-e053-2995a90a85ac2020-11-23WarningsExact identifier
unii: LMI26O6933
LamotrigineLAMOTRIGINEAsclemed USA, Inc.8ac9dc83-edb2-4ae5-8064-40f113fd3aab2020-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198429
unii: U3H27498KS
H.M.D.ALLIUM SAT, AVENA, BERBER VULG, LAPPA, PHYTOLACCA, SOLIDAGO, ALUMINA, ARG NIT, BARYTA CARB, BERYLLIUM, CADMIUM MET, CURPRUM MET, FLUORICUM ACIDUM, INDIUM, IODIUM, LITHIUM CARB, MERC SOLUB, NICCOLUM CARB, NITROGENUM OXYGENATUM, PLUMB MET, SELENIUM, STRONTIUM CARB, TITANIUM, ARSENICUM ALB, NAT MUR, NUX VOMZorex International8c53091a-904d-4756-93e4-17143c5b48e92018-12-21WarningsExact identifier
unii: LMI26O6933
LamotrigineLAMOTRIGINEDr.Reddy's Laboratories Limitede1a0da17-d67c-e44f-bd42-33c4009e4cdd2018-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
072daff2-fa12-4ade-8c41-42b00a555ade570dd712-cafe-4383-98ea-916e2ceff4962018-07-26Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 072daff2-fa12-4ade-8c41-42b00a555ade
spl set id: 570dd712-cafe-4383-98ea-916e2ceff496
5f2c6c3d-6e85-4ed4-a221-cbff7e3caed105d9f069-8061-4f3a-9ad3-0de5e6de38472018-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 5f2c6c3d-6e85-4ed4-a221-cbff7e3caed1
spl set id: 05d9f069-8061-4f3a-9ad3-0de5e6de3847
Tox-ChordALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUMEnergetix Corp6b0d1628-b20d-426e-9c84-5cceadca3f452016-11-11WarningsExact identifier
unii: LMI26O6933
LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLC380bddae-5b31-4965-96de-97711d859d112016-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
a59f10e6-5ec5-4351-9e2f-7b2d7d8bce252ea96dec-633c-4afb-9cd1-30861712be9f2015-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: a59f10e6-5ec5-4351-9e2f-7b2d7d8bce25
spl set id: 2ea96dec-633c-4afb-9cd1-30861712be9f
7332e0ea-fbd0-43fb-8d1e-f7068504c61d7332e0ea-fbd0-43fb-8d1e-f7068504c61d2010-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 7332e0ea-fbd0-43fb-8d1e-f7068504c61d
spl set id: 7332e0ea-fbd0-43fb-8d1e-f7068504c61d

Reported adverse events (FAERS/openFDA)#

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