FDA.reportPublic FDA data

NDC 50090-2129-01 - 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
50090-2129
Requested NDC
50090-2129-01
Package NDCs from labels
50090-2129-1, 50090-2129-0, 50090-2129-2, 50090-2129-01
Manufacturer
A-S Medication Solutions
Effective date
2026-08-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lamotrigine - A-S Medication SolutionsA-S Medication Solutions2026-08-05HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-2129-02023-02-07These 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
50090-2129-02023-02-07These 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
50090-2129-12023-02-07These 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
50090-2129-12023-02-07These 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
50090-2129-22023-02-07These 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
50090-2129-22023-02-07These 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
50090-2129-02023-01-30These 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
50090-2129-02023-01-30These 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
50090-2129-12023-01-30These 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
50090-2129-12023-01-30These 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
50090-2129-22023-01-30These 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
50090-2129-22023-01-30These 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2129-0Lamotrigine60 in 1 BOTTLETABLET6028
50090-2129-1Lamotrigine180 in 1 BOTTLETABLET18028
50090-2129-2Lamotrigine30 in 1 BOTTLETABLET3028

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2129LAMOTRIGINE TABLET [A-S MEDICATION SOLUTIONS]25Current NDC, Legacy NDC, 3 package rows20240824_6139a858-700c-4eb9-9f84-99d280bde326.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2129-0EA - Each50090-21299857929c-f021-4a06-9670-38a7e33dab3112021-09-07
50090-2129-1EA - Each50090-21298dfc36f2-6134-47cf-9682-9c32cf4da4c812021-09-07
50090-2129-2EA - Each50090-2129ec6a2e68-6d48-4ebf-9a49-b6acda28cbed12024-08-12

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 9 · 167 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamotrigineLAMOTRIGINEPreferred Pharmaceuticals, Inc.16323699-9bf8-43c7-b3aa-5891563778722026-05-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090170
rxcui: 282401
unii: U3H27498KS
LamotrigineLAMOTRIGINEPreferred Pharmaceuticals Inc.09a0d30d-9b8f-4c76-8cdb-8492386b22542026-05-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090170
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
SUBVENITELAMOTRIGINEOWP Pharmaceuticals, Inc.7ad18b68-ba16-4810-9c3e-27fa970454e82026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEAlembic Pharmaceuticals Limited03610cdf-7eaa-445c-a441-ff17be5a7c682026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINERising Pharma Holdings, Inc.f54690b3-bcbb-4d94-95b9-b7591af001172026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEREMEDYREPACK INC.260dc37d-6e64-4688-82dc-10a1a428af172026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEAurobindo Pharma Limitede08920c2-04a3-4fb5-acc5-0af3140f82e92026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: FZ989GH94E
LamotrigineLAMOTRIGINETorrent Pharmaceuticals Limited52df02a7-83da-4b20-9951-69790237dc242026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEAlembic Pharmaceuticals Inc.df34faa4-829e-413a-a230-cbec604eead92026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS

Reported adverse events (FAERS/openFDA)#

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