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 6 of 115 · 2,293 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
it cosmetics Your Skin But Better CC Plus Natural Matte Color Correcting Pore Refining Full Coverage Skin Balancing Serum Broad Spectrum SPF 40 SunscreenENSULIZOLE, OCTISALATE AND TITANIUM DIOXIDEIT COSMETICS, LLCf2990320-b61d-40b8-ba79-18d6b37e7f522026-06-11WarningsExact identifier
unii: 15FIX9V2JP
RE-NUTRIV AGE REVERSAL VITAL RADIANCE SERUM FOUNDATION SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC53d76b02-442e-7a5d-e063-6394a90ae1b32026-06-09WarningsExact identifier
unii: 15FIX9V2JP
FUTURIST HYDRATING COLLAGEN-PEPTIDE MAKEUP BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC53d9d689-4a86-5b9c-e063-6394a90aef182026-06-09WarningsExact identifier
unii: 15FIX9V2JP
Eryfotona Ageless Tinted Lightweight Emulsion SunscreenTITANIUM DIOXIDEISDIN Corp.293a1116-e8a2-495f-83db-20dd82ed13c22026-06-08WarningsExact identifier
unii: 15FIX9V2JP
Eryfotona Actinica TintedTITANIUM DIOXIDEISDIN Corp.97357703-0e93-4216-bd1b-a9b2027819592026-06-05WarningsExact identifier
unii: 15FIX9V2JP
SUBVENITELAMOTRIGINEOWP Pharmaceuticals, Inc.022b0913-f683-4af8-a862-f81b315909b22026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
Mineral Mattescreen SPF 40 - UntintedTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLC08671d39-3be2-d666-e063-6294a90a62072026-06-04WarningsExact identifier
unii: 15FIX9V2JP
Mineral Mattescreen SPF 40 - Golden HourTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLCc2398820-f003-707f-e053-2a95a90a69292026-06-04WarningsExact identifier
unii: 15FIX9V2JP
Epionce Daily Shield Tinted SPF 50TITANIUM DIOXIDE, ZINC OXIDEEpisciences, Inc.3d1e2921-cba9-4446-e054-00144ff8d46c2026-06-04WarningsExact identifier
unii: 15FIX9V2JP
VitaPhyte Redness Reliever Lubricant Eye DropsREDNESS RELIEVER LUBRICANT EYE DROPSGuangzhou Liyan Cosmetics Technology Co., Ltd.53d4e9b0-c9a0-797a-e063-6294a90ad0cf2026-06-04WarningsExact identifier
unii: B697894SGQ
ANESSA PERFECT UV SUNSCREEN SKINCARE MILK GBZINC OXIDE OCTOCRYLENE ETHYLHEXYL SALICYLATE HOMOSALATE TITANIUM DIOXIDEHONGKONG JIAHE INTERNATIONAL HOLDING LIMITED5354af18-50c4-5fba-e063-6394a90ace392026-06-03WarningsExact identifier
unii: 15FIX9V2JP
LamotrigineLAMOTRIGINESun Pharmaceutical Industries, Inc.b829f9b2-f0ac-408a-a6f4-18b72150227d2026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
ATOMY BB SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.b0cd27ee-4917-4800-bcdf-c6e14b28c1d12026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen White Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.ad0b9091-a990-45bf-93f4-d886be1bbffe2026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.994d5680-284e-4faf-a29b-4d28f8d46e8f2026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Matte Veil Tinted Broad Spectrum Sunscreen SPF 40ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea8d60212-18a7-42af-8bb3-bfcff7690a492026-06-02WarningsExact identifier
unii: 15FIX9V2JP
The Mineral Melt SPF30ZINC OXIDE, TITANIUM DIOXIDEDune Suncare Inc.2114fc3b-c8ce-45d2-8a82-4dc54f0adaf32026-06-02WarningsExact identifier
unii: 15FIX9V2JP
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV AIR MINERAL SERUM SUNSCREEN BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inca1acb789-5bf4-4447-b3c5-4a7d4d3013a72026-06-01WarningsExact identifier
unii: 15FIX9V2JP
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Savings Distributors LLC558178eb-1eec-af0f-e063-6394a90afad92026-06-01WarningsExact identifier
unii: B697894SGQ
KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREENTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc294e6049-12b5-4b45-ae00-8ee1d9d2a1a42026-05-29WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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