FDA.reportPublic FDA data

NDC 51672-4133-01 - 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
51672-4133
Requested NDC
51672-4133-01
Package NDCs from labels
51672-4133-6, 51672-4133-4, 51672-4133-1, 51672-4133-2, 51672-4133-3, 51672-4133-0, 51672-4133-01
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.2024-03-05HUMAN 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
51672-4133-0Lamotrigine10 in 1 BLISTER PACKTABLET1021
51672-4133-0Lamotrigine10 in 1 CARTONTABLET1021
51672-4133-1Lamotrigine100 in 1 BOTTLETABLET10021
51672-4133-2Lamotrigine500 in 1 BOTTLETABLET50021
51672-4133-3Lamotrigine1000 in 1 BOTTLETABLET100021
51672-4133-4Lamotrigine60 in 1 BOTTLETABLET6021
51672-4133-6Lamotrigine30 in 1 BOTTLETABLET3021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4133LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]15Current NDC, Legacy NDC, 7 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
51672-4133-3EA - Each51672-413379205e1c-3bba-4ca2-b9bb-f2870a7f84d912012-07-24
51672-4133-4EA - Each51672-413314874a1b-5730-4077-bcf8-40dfb3d58c7412012-07-24

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 [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

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 5 of 13 · 250 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamotrigineLAMOTRIGINEPreferred Pharmaceuticals Inc.634dbe6c-4874-4d54-aa25-be02d3341f162026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198427
unii: U3H27498KS
LamotrigineLAMOTRIGINEAvKAREa63e19c0-a093-e896-e053-2a95a90a7ccd2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
Constipation ReliefALUMINUM OXIDE, BRYONIA ALBA ROOT, SODIUM CHLORIDE, GRAPHITE, SILICON DIOXIDEHomeocare Laboratories62374240-cd14-44e2-9405-5f8996faf0472026-01-12WarningsExact identifier
unii: LMI26O6933
LamotrigineLAMOTRIGINENuCare Pharmaceuticals, Inc.47fd2592-2fc6-9787-e063-6394a90a8f012026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078525
rxcui: 198427
unii: U3H27498KS
Metex 6013METEXProfessional Complementary Health Formulas78371ca3-50a6-46f0-8ea6-7de57c5163752026-01-08WarningsExact identifier
unii: LMI26O6933
H-Clenz Drops 2026H-CLENZ DROPSProfessional Complementary Health Formulas5dd76d36-e3db-472a-82f8-30643e49eaf72026-01-08WarningsExact identifier
unii: LMI26O6933
Alumina Combination 9204ALUMINA COMBINATIONProfessional Complementary Health Formulas312cac13-2009-4b8f-a09b-9be2d2801df52026-01-08WarningsExact identifier
unii: LMI26O6933
Alopecia Formula 2139ALOPECIA FORMULAProfessional Complementary Health Formulasce0eaf67-a435-4167-b9ce-c0ff1f8a9dc22026-01-08WarningsExact identifier
unii: LMI26O6933
Colic Drops 2155COLIC DROPSProfessional Complementary Health Formulas17b9e92f-f4ed-48b4-ab02-8b7cba0a20272026-01-08WarningsExact identifier
unii: LMI26O6933
ColostatRHAMNUS PURSHIANA, SPIGELIA ANTHELMIA, TARAXACUM OFFICINALE, CAJUPUTUM, HYDRASTIS CANADENSIS, ALOE, ALUMINA, CINA, CINCHONA OFFICINALIS, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUMEnergique, Inc.3ddbed50-7ca9-493c-ba94-321c2afef60e2026-01-06WarningsExact identifier
unii: LMI26O6933
LamotrigineLAMOTRIGINEQuallent Pharmaceuticals Health LLC7977c87f-b459-486a-9edc-0a2071c46f4c2026-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINENorthwind Health Company, LLC03fd8413-df56-50ab-e063-6394a90a69502026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198427
unii: U3H27498KS
LamotrigineLAMOTRIGINENorthwind Health Company, LLCdb5f7ee5-9bd9-1819-e053-2a95a90a91df2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
unii: U3H27498KS
LAMOTRIGINELAMOTRIGINENorthwind Health Company, LLCf7587283-781b-e111-e053-6394a90ad4cc2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
unii: U3H27498KS
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
CVS Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDECVS Pharmacy, Inc.f74a2fca-902c-f68a-e053-6394a90abb882025-12-30WarningsExact identifier
unii: FZ989GH94E
Good Sense Artificial TearsPOLYVINYL ALCOHOL, POVIDONEGeiss, Destin & Dunn, Inc.9b243301-2e4b-5706-e053-2995a90a9b902025-12-30WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLGeiss, Derstin & Dunn, Inc.9b34de99-13df-201a-e053-2a95a90ae5592025-12-30WarningsExact identifier
unii: FZ989GH94E
Discount Drug Mart Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEDiscount Drug Mart, Inc.f75c2f84-a28c-5807-e053-6294a90a22952025-12-30WarningsExact identifier
unii: FZ989GH94E
Exchange Select Eye Drops Advanced Relief MoisturizerDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLArmy and Air Force Exchange Service9e475240-2df1-9bee-e053-2995a90a8d4b2025-12-30WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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