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 6 of 9 · 167 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLC9e5c2d76-47a6-4a57-b23c-2398b307380c2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEAjanta Pharma USA Inc.9dfb5f87-0150-4c26-a89f-34f1ab3895002025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEDr.Reddy's Laboratories Limiteda69542ea-5b6f-15c1-9e7a-90ac839971d32025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINENorthStar Rx LLC9ab07d6b-ae4a-a310-5572-b266676cd29e2025-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEAdvagen Pharma Limited4ca9d713-ab63-48bf-9386-29301a842e602025-11-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEZydus Pharmaceuticals USA Inc.e849033b-a3bc-408e-88de-7cd1d26609492025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEZydus Pharmaceuticals USA Inc.eb436371-d188-4803-a864-07b90c357e572025-11-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: FZ989GH94E
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: FZ989GH94E
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
unii: FZ989GH94E
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
unii: FZ989GH94E
LAMICTALLAMOTRIGINEGlaxoSmithKline LLCd7e3572d-56fe-4727-2bb4-013ccca226782025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
LAMICTAL XRLAMOTRIGINEGlaxoSmithKline LLC3e2c9a35-6a39-41d7-ad84-3c0bb8894b092025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEZydus Lifesciences Limited0f2f7421-56d4-45d0-9d2d-dc1edaede0392025-10-04Exact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEBryant Ranch Prepack8e1e4fa8-881c-4618-88f6-018ab15db44d2025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090170
rxcui: 198428
unii: U3H27498KS
LamotrigineLAMOTRIGINEBryant Ranch Prepack812bc0d8-bb31-4fb1-9f4a-f8c17cbc769c2025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090170
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEBryant Ranch Prepack53774022-ea0c-42a9-a720-dc755c77b8512025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090170
rxcui: 198427
unii: U3H27498KS
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: FZ989GH94E
LamotrigineLAMOTRIGINECoupler LLC3dfdcc2d-b7c5-7abf-e063-6394a90a24a62025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
unii: U3H27498KS
LamotrigineLAMOTRIGINEBryant Ranch Prepackd33c4293-347c-49a1-9d98-f291c3dab6da2025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198428
unii: U3H27498KS

Reported adverse events (FAERS/openFDA)#

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