NDC 0078-0337-61 - Trileptal

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
0078-0337
Requested NDC
0078-0337-61
Package NDCs from labels
0078-0337-05, 0078-0337-61, 0078-0337-06
Manufacturer
Novartis Pharmaceuticals Corporation
Effective date
2025-12-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Trileptal - Novartis Pharmaceuticals CorporationNovartis Pharmaceuticals Corporation2025-12-16HUMAN PRESCRIPTION DRUG LABEL
Trileptal - PD-Rx Pharmaceuticals, Inc.PD-Rx Pharmaceuticals, Inc.2022-02-17HUMAN PRESCRIPTION DRUG LABEL
Trileptal - REMEDYREPACK INC.REMEDYREPACK INC.2019-09-12HUMAN PRESCRIPTION DRUG LABEL
Trileptal - Physicians Total Care, Inc.Physicians Total Care, Inc.2012-02-17HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0337-05Trileptal100 in 1 BOTTLETABLET, FILM COATED10039
0078-0337-06Trileptal100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10039
0078-0337-61Trileptal1 in 1 BLISTER PACKTABLET, FILM COATED139

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0337TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]37Current NDC, Legacy NDC, 3 package rows20250122_4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0337-05EA - Each0078-0337b4424458-cb22-4259-b023-555e56822f5312012-07-24
0078-0337-06EA - Each0078-0337d0529c55-60b2-4ed9-88df-85d53014d38312012-07-24
0078-0337-61EA - Each0078-0337823c9f76-ba1c-43a6-b5d0-cd070e3b2c1212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXCARBAZEPINEACTIVE INGREDIENTVZI5B1W380TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
OXCARBAZEPINEACTIVE MOIETYVZI5B1W380TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
ALCOHOLINACTIVE INGREDIENT3K9958V90MTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
LEMONINACTIVE INGREDIENT24RS0A988OTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
PLUMINACTIVE INGREDIENT67M3EQ6BE1TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
SORBITOLINACTIVE INGREDIENT506T60A25RTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
TALCINACTIVE INGREDIENT7SEV7J4R1UTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
WATERINACTIVE INGREDIENT059QF0KO0RTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
OXCARBAZEPINEACTIVE INGREDIENTVZI5B1W380TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]18
OXCARBAZEPINEACTIVE MOIETYVZI5B1W380TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]18
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]18
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]18
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]18
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]18
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]18
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ATRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]18
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]18
TALCINACTIVE INGREDIENT7SEV7J4R1UTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]18
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]18
OXCARBAZEPINEACTIVE INGREDIENTVZI5B1W380TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
OXCARBAZEPINEACTIVE MOIETYVZI5B1W380TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ATRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]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 169 · 3,371 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
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
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
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
OxcarbazepineOXCARBAZEPINEZameer Pharmaceuticals LLC8841174a-9f4b-424f-a50d-01478f2aeb292026-08-26Warnings, Adverse reactionsExact identifier
rxcui: 312138
rxcui: 312136
rxcui: 312137
unii: VZI5B1W380
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
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
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
Electrolyte PlusKALI MURIATICUM, L-ARGININE, L-CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, BORAX, CHROMIUM OXYDATUM, FERRUM MURIATICUM, KALI CARBONICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, NATRUM MURIATICUM, ZINCUM GLUCONICUM, CUPRUM METALLICUM, KALI PHOSPHORICUM, NICCOLUM METALLICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, MANGANUM CARBONICUMDeseret Biologicals, Inc.e3564733-8b88-4753-9077-9d74004d8ec92026-08-25WarningsExact identifier
unii: PQ6CK8PD0R
Mirexa MiniMIREXA MINIOncora Pharma, LLCea48f64a-9a70-40df-ba25-0983532730892026-08-25Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
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
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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