FDA.reportPublic FDA data

NDC 70518-1908-01 - 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
70518-1908
Requested NDC
70518-1908-01
Package NDCs from labels
70518-1908-0, 70518-1908-1, 70518-1908-2, 70518-1908-3, 70518-1908-4, 70518-1908-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-07-16
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.2026-07-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1908-0Lamotrigine30 in 1 BLISTER PACKTABLET3022
70518-1908-1Lamotrigine30 in 1 BLISTER PACKTABLET3022
70518-1908-2Lamotrigine30 in 1 BLISTER PACKTABLET3022
70518-1908-3Lamotrigine180 in 1 BOTTLE, PLASTICTABLET18022
70518-1908-4Lamotrigine30 in 1 BOTTLE, PLASTICTABLET3022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1908LAMOTRIGINE TABLET [REMEDYREPACK INC.]17Current NDC, Legacy NDC, 5 package rows20250507_1b5646a9-4724-44b8-8cd0-9c14f5e87f86.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 2 of 9 · 170 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
rxcui: 282401
unii: U3H27498KS
LamotrigineLAMOTRIGINEREMEDYREPACK INC.1b5646a9-4724-44b8-8cd0-9c14f5e87f862026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090170
ndc (package): 70518-1908-3
ndc (package): 70518-1908-0
ndc (package): 70518-1908-2
ndc (package): 70518-1908-1
ndc (package): 70518-1908-4
ndc (product): 70518-1908
ndc11 (package): 70518190801
rxcui: 282401
spl id: 56b998d0-b4b3-5a4a-e063-6394a90a85ad
spl set id: 1b5646a9-4724-44b8-8cd0-9c14f5e87f86
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
application number: ANDA090170
rxcui: 282401
unii: U3H27498KS
LamotrigineLAMOTRIGINEREMEDYREPACK INC.3ed4590d-71e3-4208-b6c0-98330acc7b852026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090170
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEREMEDYREPACK INC.de7f61ca-e3c0-4a09-b664-0df2de6a0c302026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: FZ989GH94E
LamotrigineLAMOTRIGINECoupler LLC545fcc0e-1e2b-bdcb-e063-6294a90a4ac72026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090170
rxcui: 198428
unii: U3H27498KS
LamotrigineLAMOTRIGINEBryant Ranch Prepackb1601109-5c17-4482-9257-1e0be7546e8f2026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090170
rxcui: 282401
unii: U3H27498KS
SUBVENITELAMOTRIGINEOWP Pharmaceuticals, Inc.022b0913-f683-4af8-a862-f81b315909b22026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINESun Pharmaceutical Industries, Inc.b829f9b2-f0ac-408a-a6f4-18b72150227d2026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEBryant Ranch Prepack68a4dac2-5015-40c5-88ca-204098c3b2882026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198428
unii: U3H27498KS
LamotrigineLAMOTRIGINECoupler LLC52b8be5c-ef88-dfa7-e063-6394a90a05002026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090170
rxcui: 198427
unii: U3H27498KS
LamotrigineLAMOTRIGINEAurobindo Pharma Limiteda9a4309e-fe43-4a26-a30f-c6577d6503362026-05-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
LamotrigineLAMOTRIGINEAlembic Pharmaceuticals Limitedccb33cd0-e5f7-4a50-8b55-ad7c432cdb772026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEUnichem Pharmaceuticals (USA), Inc.4b72ea7a-a0b0-4980-84ad-84f64e2e63682026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090170
ndc (product): 29300-111
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
spl id: 503a737a-92a2-4a67-bfbb-e08788c101df
spl set id: 4b72ea7a-a0b0-4980-84ad-84f64e2e6368
unii: U3H27498KS

Reported adverse events (FAERS/openFDA)#

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