FDA.reportPublic FDA data

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 5 of 6 · 106 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamotrigineLAMOTRIGINEBryant Ranch Prepack4bbc140c-6092-416d-865d-49b89c5ecdd02025-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198427
unii: U3H27498KS
LamotrigineLAMOTRIGINEBryant Ranch Prepackcf03f130-067f-401c-8501-0d78a989a3192025-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINENuCare Pharmaceuticals,Inc.065e97c9-3c5f-16e6-e063-6294a90a13fc2025-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198427
unii: U3H27498KS
Lamotrigine ERLAMOTRIGINE ERDirect_Rxfaccacb7-65f1-cb00-e053-6394a90a9fcb2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LAMOTRIGINELAMOTRIGINEDIRECT RXa835b697-2beb-1ba8-e053-2995a90a470c2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
unii: U3H27498KS
LamotrigineLAMOTRIGINEAdvanced Rx Pharmacy of Tennessee, LLCf7a86237-ece4-7cc4-e053-6294a90a13082024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
unii: U3H27498KS
LamotrigineLAMOTRIGINEDr.Reddy's Laboratories Limited44670496-41ea-36a1-c435-32e359766a742024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTIRIGINEZydus Lifesciences Limitedecb7a528-699f-4e51-9887-dee60456da2f2024-11-30Exact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEAlembic Pharmaceuticals Limitedfaee013c-cad2-4abb-904c-e6ff79ba778c2024-10-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINENCS HealthCare of KY, LLC dba Vangard Labse243e803-e95f-47a6-a6da-5fed657f44622024-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
LAMOTRIGINELAMOTRIGINENuCare Pharmaceuticals,Inc.1bbbe2a2-a9e8-8c13-e063-6394a90a96272024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078947
ndc (package): 68071-3607-6
ndc (product): 68071-3607
ndc11 (package): 68071360706
rxcui: 198427
spl id: 1bbbeda6-9835-6c1c-e063-6294a90ad1ab
spl set id: 1bbbe2a2-a9e8-8c13-e063-6394a90a9627
unii: U3H27498KS
Lamotrigine ERLAMOTRIGINE ERDirect_rx1b42a7cf-86d8-e506-e063-6394a90a3c9b2024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEBryant Ranch Prepack36f383af-8b71-4875-85ef-3a7a8b1d88052024-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEProficient Rx LPffa46cb2-16e7-45f3-9940-5cb88d0cda9d2024-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEProficient Rx LP6f7e59d2-4311-42a0-93a0-b29b0417d96f2024-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEA-S Medication Solutions5a9575bb-230e-46ae-b58e-41554bad45eb2023-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198428
unii: U3H27498KS
lamotrigineLAMOTRIGINE EXTENDED-RELEASEProficient Rx LP39efe933-bfed-4a6a-b270-0883871c51862023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LAMOTRIGINELAMOTRIGINEA-S Medication Solutions4e6cc1ad-55cd-4c7f-878c-fa6716e958972023-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078947
rxcui: 198429
unii: U3H27498KS
lamotrigineLAMOTRIGINE CHEWABLE DISPERSIBLEAlembic Pharmaceuticals Limitedae6522d4-d824-44aa-afe0-70cdcbd845af2023-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEAscend Laboratories, LLC70cd448a-2921-4c69-bdf2-5a6ce883bd072022-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS

Reported adverse events (FAERS/openFDA)#

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