NDC 0378-5615-12 - Levetiracetam

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
0378-5615
Requested NDC
0378-5615-12
Package NDCs from labels
0378-5615-78, 0378-5615-05, 0378-5615-12
Manufacturer
Safecor Health LLC
Effective date
2026-04-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levetiracetam - Safecor Health LLCSafecor Health LLC2026-04-09HUMAN PRESCRIPTION DRUG LABEL
Levetiracetam - Mylan Institutional Inc.Mylan Institutional Inc.2025-11-12HUMAN PRESCRIPTION DRUG LABEL
Levetiracetam - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2025-04-12HUMAN PRESCRIPTION DRUG LABEL
Levetiracetam - NCS HealthCare of KY, Inc dba Vangard LabsNCS HealthCare of KY, Inc dba Vangard Labs2015-10-28HUMAN PRESCRIPTION DRUG LABEL
Levetiracetam - State of Florida DOH Central PharmacyState of Florida DOH Central Pharmacy2010-05-26HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-5615-05Levetiracetam500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50041
0378-5615-78Levetiracetam120 in 1 BOTTLE, PLASTICTABLET, FILM COATED12041

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-5615LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]38Current NDC, Legacy NDC, 2 package rows20241011_0a987d59-560f-4650-96ec-31aec81953b5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-5615-05EA - Each0378-56157f134995-63cc-4fb8-b3e5-12905634549e12012-07-24
0378-5615-07EA - Each0378-5615f660511c-c967-4caf-9a03-8d9658cd1e8f12013-02-13
0378-5615-12EA - Each0378-561581639b71-4b94-4bc1-bfea-9deb5d61ac2212013-02-13
0378-5615-78EA - Each0378-5615adb6ca6e-bb97-4abe-b59f-df36767ecefa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]16
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]16
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]16
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]16
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]16
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IELEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]16
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IELEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]16
POVIDONESINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]16
POVIDONESINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]16
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]16
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]16
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
TRIACETININACTIVE INGREDIENTXHX3C3X673LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
TRIACETININACTIVE INGREDIENTXHX3C3X673LEVETIRACETAM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]16
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IELEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
POVIDONESINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
TRIACETININACTIVE INGREDIENTXHX3C3X673LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOLEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IELEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ALEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIACETININACTIVE INGREDIENTXHX3C3X673LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

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 148 · 2,948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
LevetiracetamLEVETIRACETAMCardinal Health 107, LLC0348fec4-d919-4307-ac90-35360819bc002026-09-04Warnings, Adverse reactionsExact identifier
rxcui: 311289
unii: 44YRR34555
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.2d307850-0ed5-4f32-ac62-0e1e2fe27a7a2026-09-03Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
Levetiracetam ERLEVETIRACETAMREMEDYREPACK INC.2d57f22f-fecc-466e-a444-87708c7c2f802026-08-27Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMDirect_Rx5517b148-1eff-6421-e063-6394a90a94982026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 387003
unii: 44YRR34555
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
LEVETIRACETAMLEVETIRACETAMREMEDYREPACK INC.9bdef24b-c50e-4e6a-8650-59d78009f4722026-08-26Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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