FDA.reportPublic FDA data

NDC 80425-0289-01 - 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
80425-0289
Requested NDC
80425-0289-01
Package NDCs from labels
80425-0289-1, 80425-0289-2, 80425-0289-3, 80425-0289-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lamotrigine - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0289-1Lamotrigine30 in 1 BOTTLETABLET302
80425-0289-2Lamotrigine60 in 1 BOTTLETABLET602
80425-0289-3Lamotrigine90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0289LAMOTRIGINE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f7a86237-ece4-7cc4-e053-6294a90a1308.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0289-1EA - Each80425-0289902fd383-e045-4a04-90d7-c3bbdb9daed712023-04-07
80425-0289-2EA - Each80425-0289ad005172-4479-47ce-9e8b-01da723d13c112023-04-07
80425-0289-3EA - Each80425-0289cf9f90dc-57c1-4142-8119-8d5139a8e74412023-04-07

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 6 · 106 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
LamotrigineLAMOTRIGINEAmerican Health Packaging6034a8b8-9e80-43ca-b84f-ea82f788268c2026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198428
rxcui: 198429
unii: U3H27498KS
lamotrigineLAMOTRIGINEAlembic Pharmaceuticals Inc.05cba628-b12c-44d8-89a8-3522fe417cc12026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEAlembic Pharmaceuticals Inc.4bd7193f-a81a-4909-90c2-7f324fc6ddfd2026-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
lamotrigineLAMOTRIGINE EXTENDED-RELEASECamber Pharmaceuticals Ince45bd69f-3580-ff15-e053-2a95a90a46152026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEGlenmark Pharmaceuticals Inc., USA50fcf452-2d21-493e-a1dd-0c6ea9ac61842026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
Lamotrigine Extended-ReleaseLAMOTRIGINEPar Health USA, LLCd5ec4d58-c669-4ab4-ba62-b710075368542026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
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
LamotrigineLAMOTRIGINENuCare Pharmaceuticals, Inc.47fd2592-2fc6-9787-e063-6394a90a8f012026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198427
unii: U3H27498KS
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
application number: ANDA090170
rxcui: 282401
unii: U3H27498KS
LAMOTRIGINELAMOTRIGINENorthwind Health Company, LLCf7587283-781b-e111-e053-6394a90ad4cc2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
unii: U3H27498KS

Reported adverse events (FAERS/openFDA)#

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