FDA.reportPublic FDA data

NDC 67046-1573-03 - 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
67046-1573
Requested NDC
67046-1573-03
Package NDCs from labels
67046-1573-3, 67046-1573-03
Manufacturer
Coupler LLC
Effective date
2025-09-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lamotrigine - Coupler LLCCoupler LLC2025-09-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-1573-3Lamotrigine30 in 1 BLISTER PACKTABLET301

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 1 of 6 · 109 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamotrigineLAMOTRIGINECardinal Health 107, LLCbeb24a4f-ab0b-435a-b60b-2b8d565ecd752026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198427
unii: U3H27498KS
LamotrigineLAMOTRIGINECardinal Health 107, LLC20e156df-a2b6-4710-b526-0419cd17dd332026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198427
unii: U3H27498KS
LamotrigineLAMOTRIGINEAmneal Pharmaceuticals LLC0833d3df-2df1-4abd-abe0-7fb2c0253c802026-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEA-S Medication Solutions6139a858-700c-4eb9-9f84-99d280bde3262026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
unii: U3H27498KS
LamotrigineLAMOTRIGINEDr. Reddys Laboratories Inc.54ea1ec3-876b-4d3a-a92b-1a6d70951de02026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LAMOTRIGINELAMOTRIGINEGolden State Medical Supply, Inc.57f04b9b-06cd-8044-e063-6394a90ae7332026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEAmerican Health Packaging35aa48a2-2ce6-4a6e-bf5a-1bc6111d12342026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198427
unii: U3H27498KS
LAMOTRIGINELAMOTRIGINEREMEDYREPACK INC.50d46278-636a-470e-afcc-d3c8bd844e462026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198427
unii: U3H27498KS
LamotrigineLAMOTRIGINEAlembic Pharmaceuticals Inc.60958229-5b5f-49e2-97f4-a8722138f7ce2026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
LAMOTRIGINELAMOTRIGINEREMEDYREPACK INC.1d7c2d52-a78e-4508-8853-ba306cdeeaba2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
unii: U3H27498KS
LamotrigineLAMOTRIGINEREMEDYREPACK INC.15d801a0-f0a5-40c1-bc88-d5ba9a02c6962026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198427
unii: U3H27498KS
LamotrigineLAMOTRIGINEREMEDYREPACK INC.d1691a60-ff0a-4755-b445-1d78309d5af02026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198428
unii: U3H27498KS
LamotrigineLAMOTRIGINEREMEDYREPACK INC.346f8af3-b850-48e4-bd6e-82ecafca86d22026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEREMEDYREPACK INC.f5761818-4eaf-4335-a77a-9cd703278ded2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198427
unii: U3H27498KS
LamotrigineLAMOTRIGINEREMEDYREPACK INC.fa679e97-3b3d-4bf2-8de7-da3a89e38b372026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LAMOTRIGINELAMOTRIGINETorrent Pharmaceuticals Limited22225cc4-028e-43ad-8e1f-dcebdc244ecb2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEREMEDYREPACK INC.6ef17301-6c0b-4941-a84d-12243875d2e22026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078956
rxcui: 282401
unii: U3H27498KS
LamotrigineLAMOTRIGINEREMEDYREPACK INC.1b5646a9-4724-44b8-8cd0-9c14f5e87f862026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
unii: U3H27498KS
LAMOTRIGINELAMOTRIGINETorrent Pharmaceuticals Limited3448839b-4933-4ef9-a80a-9e504d2c56962026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINECoupler LLC55f41c7e-03a6-b84c-e063-6294a90a7d822026-07-06Boxed 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.