NDC 70518-2406-01 - 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
70518-2406
Requested NDC
70518-2406-01
Package NDCs from labels
70518-2406-1, 70518-2406-0, 70518-2406-3, 70518-2406-2, 70518-2406-4, 70518-2406-5, 70518-2406-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-07-23
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.2026-07-23HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
70518-2406-02023-03-09These 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
70518-2406-02023-03-09These 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
70518-2406-02023-03-09These 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
70518-2406-22023-03-09These 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
70518-2406-22023-03-09These 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
70518-2406-22023-03-09These 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
70518-2406-02023-01-30These 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
70518-2406-02023-01-30These 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
70518-2406-02023-01-30These 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
70518-2406-22023-01-30These 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
70518-2406-22023-01-30These 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
70518-2406-22023-01-30These 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
70518-2406-0Lamotrigine30 in 1 BOXTABLET3015
70518-2406-1Lamotrigine1 in 1 POUCHTABLET115
70518-2406-2Lamotrigine100 in 1 BOXTABLET10015
70518-2406-3Lamotrigine1 in 1 POUCHTABLET115
70518-2406-4Lamotrigine30 in 1 BOTTLE, PLASTICTABLET3015
70518-2406-5Lamotrigine90 in 1 BOTTLE, PLASTICTABLET9015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2406LAMOTRIGINE TABLET [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 6 package rows20250316_346f8af3-b850-48e4-bd6e-82ecafca86d2.zip

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 9 of 9 · 167 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamotrigineLAMOTRIGINEAscend Laboratories, LLC70cd448a-2921-4c69-bdf2-5a6ce883bd072022-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEScieGen Pharmaceuticals, Inc.de700ac1-4048-467e-abb1-238953261a972022-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEProficient Rx LP52273d60-3f27-4846-bf40-014ebcf094172022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090170
rxcui: 198427
unii: U3H27498KS
LamotrigineLAMOTRIGINEProficient Rx LPb94ae2e4-e276-40c1-bc25-da980194fc992022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090170
rxcui: 282401
unii: U3H27498KS
LamotrigineLAMOTRIGINEAsclemed USA, Inc.8ac9dc83-edb2-4ae5-8064-40f113fd3aab2020-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090170
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEDr.Reddy's Laboratories Limitede1a0da17-d67c-e44f-bd42-33c4009e4cdd2018-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLC380bddae-5b31-4965-96de-97711d859d112016-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS

Reported adverse events (FAERS/openFDA)#

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