FDA.reportPublic FDA data

NDC 70518-3139-2 - 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
70518-3139
Requested NDC
70518-3139-2
Package NDCs from labels
70518-3139-0, 70518-3139-2, 70518-3139-1, 70518-3139-3
Manufacturer
REMEDYREPACK INC.
Effective date
2024-03-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lamotrigine - REMEDYREPACK INC.REMEDYREPACK INC.2024-03-13HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3139-02023-03-17C16284748780-1f386c64a-226e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE tablets, for oral use Initial U.S. Approval: 1994
70518-3139-02023-01-30C16284748780-1f386c64a-226e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE tablets, for oral use Initial U.S. Approval: 1994

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 2 of 6 · 108 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamotrigineLAMOTRIGINEREMEDYREPACK INC.3ed4590d-71e3-4208-b6c0-98330acc7b852026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEREMEDYREPACK INC.de7f61ca-e3c0-4a09-b664-0df2de6a0c302026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINECoupler LLC545fcc0e-1e2b-bdcb-e063-6294a90a4ac72026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198428
unii: U3H27498KS
LamotrigineLAMOTRIGINEBryant Ranch Prepackb1601109-5c17-4482-9257-1e0be7546e8f2026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
unii: U3H27498KS
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
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEBryant Ranch Prepack68a4dac2-5015-40c5-88ca-204098c3b2882026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
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
application number: ANDA078956
ndc (product): 65862-228
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
spl id: 977310c4-6d07-4690-b857-d2577e4ff60c
spl set id: a9a4309e-fe43-4a26-a30f-c6577d650336
unii: U3H27498KS
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
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
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.