NDC 68071-3607-06 - 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
68071-3607
Requested NDC
68071-3607-06
Package NDCs from labels
68071-3607-6, 68071-3607-06
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-06-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LAMOTRIGINE - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2024-06-25HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3607-6LAMOTRIGINE60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3607LAMOTRIGINE TABLET [NUCARE PHARMACEUTICALS,INC.]1Current NDC, 1 package rows20240627_1bbbe2a2-a9e8-8c13-e063-6394a90a9627.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 6 of 6 · 106 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
rxcui: 198427
unii: U3H27498KS
LamotrigineLAMOTRIGINEProficient Rx LPb94ae2e4-e276-40c1-bc25-da980194fc992022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
unii: U3H27498KS
LamotrigineLAMOTRIGINEAsclemed USA, Inc.8ac9dc83-edb2-4ae5-8064-40f113fd3aab2020-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
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.