FDA.reportPublic FDA data

NDC 64679-271-03 - 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
64679-271
Requested NDC
64679-271-03
Package NDCs from labels
64679-271-01, 64679-271-02, 64679-271-03, 64679-271-04
Manufacturer
Wockhardt USA LLC. | Atlantide Pharmaceuticals AG | Wockhardt Limited
Effective date
2020-12-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lamotrigine - Wockhardt USA LLC. | Atlantide Pharmaceuticals AG | Wockhardt LimitedWockhardt USA LLC. | Atlantide Pharmaceuticals AG | Wockhardt Limited2020-12-27HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
64679-271-012025-12-23These highlights do not include all the information needed to use lamotrigine extended-release tablets safely and effectively. See full prescribing information for lamotrigine extended-release tablets. LAMOTRIGINE extended-release tablets, for oral use Initial U.S. Approval: 1994
64679-271-022025-12-23These highlights do not include all the information needed to use lamotrigine extended-release tablets safely and effectively. See full prescribing information for lamotrigine extended-release tablets. LAMOTRIGINE extended-release tablets, for oral use Initial U.S. Approval: 1994
64679-271-042025-12-23These highlights do not include all the information needed to use lamotrigine extended-release tablets safely and effectively. See full prescribing information for lamotrigine extended-release tablets. LAMOTRIGINE extended-release tablets, for oral use Initial U.S. Approval: 1994
64679-271-012023-01-30These highlights do not include all the information needed to use lamotrigine extended-release tablets safely and effectively. See full prescribing information for lamotrigine extended-release tablets. LAMOTRIGINE extended-release tablets, for oral use Initial U.S. Approval: 1994
64679-271-022023-01-30These highlights do not include all the information needed to use lamotrigine extended-release tablets safely and effectively. See full prescribing information for lamotrigine extended-release tablets. LAMOTRIGINE extended-release tablets, for oral use Initial U.S. Approval: 1994
64679-271-042023-01-30These highlights do not include all the information needed to use lamotrigine extended-release tablets safely and effectively. See full prescribing information for lamotrigine extended-release tablets. LAMOTRIGINE extended-release tablets, for oral use Initial U.S. Approval: 1994

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64679-271LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]5Legacy NDC20201228_0e9b23d9-0813-4fb5-848d-776453f361f7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-271-01EA - Each64679-271898db821-9b41-4321-b09a-c25cbab6eda012013-02-13
64679-271-02EA - Each64679-2712487e671-fa12-49d2-8a3e-97d067ea1d0b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]2
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]2
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFLAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JLAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1ULAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT USA LLC.]2

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 13 of 114 · 2,264 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineCALAMINE 8%, ZINC OXIDE 8%Farmacias De Similares TX LLC4ecd0add-11c9-cf3b-e063-6394a90adff62026-04-06WarningsExact identifier
unii: 1K09F3G675
EltaMD Skincare UV AOX Elements SPF50 TintedTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc2c74209d-9b88-4c32-ad42-cd6de16c1fef2026-04-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV Restore TintedTITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc4fc18856-01b3-43ed-9e1b-b4394e31aa3c2026-04-03WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen for baby SPF50plusOCTOCRYLENE,ETHYLHEXYL METHOXYCINNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATEGuangzhou Senmai Biotechnology Co., Ltd.1cb7fbca-0874-ae53-e063-6294a90ab42a2026-04-02WarningsExact identifier
unii: 15FIX9V2JP
TiZO3TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD4e7bdec2-abcc-0267-e063-6394a90ae47a2026-04-02WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc17b47994-82d6-4f9d-8249-bdb55106c9b32026-04-02WarningsExact identifier
unii: 15FIX9V2JP
Clinical Skin Filter Tinted SunscreenCLINICAL SKIN FILTER TINTED SUNSCREENBY KIN AESTHETICS LLC4e69a8a3-8dbb-577a-e063-6294a90a6a232026-04-01WarningsExact identifier
unii: 15FIX9V2JP
Krx Aesthetics All Day Glow SunblockerKRX AESTHETICS ALL DAY GLOW SUNBLOCKERBY KIN AESTHETICS LLC4e69df43-393b-bc09-e063-6394a90a275a2026-04-01WarningsExact identifier
unii: 15FIX9V2JP
spf 50 mineral powder sunscreenTITANIUM DIOXIDE, ZINC OXIDESmalls Brand LLC DBA Roe Wellnessf8762dd1-0484-74ea-e053-6294a90ac1122026-03-31WarningsExact identifier
unii: 15FIX9V2JP
SeranovaTM ULTRALIGHT SPF50 SERUMSERANOVATM ULTRALIGHT SPF50 SERUMGuangzhou Ariel Biotech Co., Ltd.4e5d716d-2b2d-d42f-e063-6294a90a1e522026-03-31WarningsExact identifier
unii: 15FIX9V2JP
LAMOTRIGINE KitLAMOTRIGINEOWP Pharmaceuticals, Inc.474fb321-575c-4b97-9dbe-080061652ee42026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
SUBVENITELAMOTRIGINEOWP Pharmaceuticals, Inc.7ad18b68-ba16-4810-9c3e-27fa970454e82026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS DARK SHADETITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLC4e0bd355-99c6-8cf4-e063-6294a90ab4b32026-03-27WarningsExact identifier
unii: 15FIX9V2JP
LamotrigineLAMOTRIGINEAlembic Pharmaceuticals Limited03610cdf-7eaa-445c-a441-ff17be5a7c682026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: B697894SGQ
SUNNYSIDEKICK UVA/UVB Broad Spectrum SPF 30 Brush-On MineralZINC OXIDE, TITANIUM DIOXIDEClassic Cosmetics LLC4df3b8c0-71bc-acdd-e063-6394a90a35c02026-03-26WarningsExact identifier
unii: 15FIX9V2JP
LamotrigineLAMOTRIGINERising Pharma Holdings, Inc.f54690b3-bcbb-4d94-95b9-b7591af001172026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
Silkscreen Sheer Tint Mineral Light-MediumTITANIUM DIOXIDE, ZINC OXIDECurology4ddbe349-6880-a5fc-e063-6294a90a275c2026-03-25WarningsExact identifier
unii: 15FIX9V2JP
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: B697894SGQ
BANANA BOATTITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLC4e0450ca-147a-91d7-e063-6394a90ae73b2026-03-25WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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