FDA.reportPublic FDA data

NDC 51672-4131-01 - 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
51672-4131
Requested NDC
51672-4131-01
Package NDCs from labels
51672-4131-6, 51672-4131-4, 51672-4131-1, 51672-4131-3, 51672-4131-0, 51672-4131-01
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 - NuCare Pharmaceuticals, Inc.NuCare Pharmaceuticals, Inc.2026-01-09HUMAN PRESCRIPTION DRUG LABEL
Lamotrigine - REMEDYREPACK INC.REMEDYREPACK INC.2025-02-24HUMAN 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
51672-4131-0Lamotrigine10 in 1 CARTONTABLET1021
51672-4131-0Lamotrigine10 in 1 BLISTER PACKTABLET1021
51672-4131-1Lamotrigine100 in 1 BOTTLETABLET10021
51672-4131-3Lamotrigine1000 in 1 BOTTLETABLET100021
51672-4131-4Lamotrigine60 in 1 BOTTLETABLET6021
51672-4131-6Lamotrigine30 in 1 BOTTLETABLET3021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4131LAMOTRIGINE 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
51672-4131-1EA - Each51672-41319e789f5b-afd2-4c6b-89cd-6523a06e210412012-07-24
51672-4131-3EA - Each51672-4131b24e697b-4fda-49a1-9d0c-8454f4042bb912012-07-24

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 3 of 13 · 250 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUBVENITELAMOTRIGINEOWP Pharmaceuticals, Inc.022b0913-f683-4af8-a862-f81b315909b22026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINESun Pharmaceutical Industries, Inc.b829f9b2-f0ac-408a-a6f4-18b72150227d2026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078525
ndc (package): 51672-4130-0
ndc (package): 51672-4132-2
ndc (package): 51672-4133-0
ndc (package): 51672-4132-3
ndc (package): 51672-4133-2
ndc (package): 51672-4133-6
ndc (package): 51672-4131-0
ndc (package): 51672-4131-6
ndc (package): 51672-4133-1
ndc (package): 51672-4130-4
ndc (package): 51672-4132-6
ndc (package): 51672-4130-1
ndc (package): 51672-4131-3
ndc (package): 51672-4131-1
ndc (package): 51672-4132-4
ndc (package): 51672-4130-3
ndc (package): 51672-4130-6
ndc (package): 51672-4132-1
ndc (package): 51672-4132-0
ndc (package): 51672-4131-4
ndc (package): 51672-4133-4
ndc (package): 51672-4133-3
ndc (product): 51672-4130
ndc (product): 51672-4132
ndc (product): 51672-4133
ndc (product): 51672-4131
ndc11 (package): 51672413101
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
spl id: 5356e9be-0f6c-ebbb-e063-6394a90aac4d
spl set id: b829f9b2-f0ac-408a-a6f4-18b72150227d
unii: U3H27498KS
LamotrigineLAMOTRIGINEBryant Ranch Prepack68a4dac2-5015-40c5-88ca-204098c3b2882026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078525
rxcui: 198428
unii: U3H27498KS
LamotrigineLAMOTRIGINECoupler LLC52b8be5c-ef88-dfa7-e063-6394a90a05002026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198427
unii: U3H27498KS
LamotrigineLAMOTRIGINEAurobindo Pharma Limiteda9a4309e-fe43-4a26-a30f-c6577d6503362026-05-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
LamotrigineLAMOTRIGINEAlembic Pharmaceuticals Limitedccb33cd0-e5f7-4a50-8b55-ad7c432cdb772026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEUnichem Pharmaceuticals (USA), Inc.4b72ea7a-a0b0-4980-84ad-84f64e2e63682026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEPreferred Pharmaceuticals, Inc.16323699-9bf8-43c7-b3aa-5891563778722026-05-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
unii: U3H27498KS
LamotrigineLAMOTRIGINEPreferred Pharmaceuticals Inc.09a0d30d-9b8f-4c76-8cdb-8492386b22542026-05-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198427
unii: U3H27498KS
LamotrigineLAMOTRIGINEAvKAREfcdb94a8-33be-6375-98ef-6933999d157f2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEMajor Pharmaceuticals12e0be85-0961-4fe0-b973-83251ecf0f652026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198427
unii: U3H27498KS
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: FZ989GH94E
LamotrigineLAMOTRIGINEActavis Pharma, Inc.87beaf22-593d-4170-bb58-332c615ef90d2026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
lamotrigineLAMOTRIGINE EXTENDED-RELEASEREMEDYREPACK INC.65748114-c59c-4ebb-977e-d4aab5764dd32026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEPar Health USA, LLC003663e5-c0c7-4fc1-a64d-313f2a5b10d22026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
unii: FZ989GH94E
LamotrigineLAMOTRIGINENordic Pharma, Inc.67cf961e-02b9-4a99-944f-43a55df6a5442026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LAMOTRIGINE KitLAMOTRIGINEOWP Pharmaceuticals, Inc.474fb321-575c-4b97-9dbe-080061652ee42026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198427
unii: U3H27498KS

Reported adverse events (FAERS/openFDA)#

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