FDA.reportPublic FDA data

NDC 63459-548-04 - FENTORA

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
63459-548
Requested NDC
63459-548-04
Package NDCs from labels
63459-548-04, 63459-548-28
Manufacturer
Cephalon, LLC
Effective date
2023-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FENTORA - Cephalon, LLCCephalon, LLC2023-12-31HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63459-548FENTORA (FENTANYL) TABLET [CEPHALON, LLC]31Legacy NDC20241018_8f549d95-985b-f783-1ebb-ef57bd2ecb05.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63459-548-04EA - Each63459-5481888c9d2-5870-40eb-9882-5bfa40662b2212012-07-24
63459-548-28EA - Each63459-5485e01f3ae-f449-4a7f-a09f-50ab662fd4de12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENTANYL CITRATEACTIVE INGREDIENTMUN5LYG46HFENTORA (FENTANYL CITRATE) TABLET [CEPHALON, INC.]10
FENTANYLACTIVE MOIETYUF599785JZFENTORA (FENTANYL CITRATE) TABLET [CEPHALON, INC.]10
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPFENTORA (FENTANYL CITRATE) TABLET [CEPHALON, INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FENTORA (FENTANYL CITRATE) TABLET [CEPHALON, INC.]10
MANNITOLINACTIVE INGREDIENT3OWL53L36AFENTORA (FENTANYL CITRATE) TABLET [CEPHALON, INC.]10
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOFENTORA (FENTANYL CITRATE) TABLET [CEPHALON, INC.]10
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TFENTORA (FENTANYL CITRATE) TABLET [CEPHALON, INC.]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FENTORA (FENTANYL CITRATE) TABLET [CEPHALON, INC.]10

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 15 of 20 · 388 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium BicarbonateSODIUM BICARBONATEBryant Ranch Prepack4493d7c5-f2c3-416e-a5c1-35398fc7f61d2024-02-29Boxed warning, WarningsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirsta5eedf57-2783-b3d0-e053-2a95a90a9ff52024-02-22Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Grain and Soy Allergen MixADENOSINUM TRIPHOSPHORICUM DINATRUM, QUERCETIN, RUTIN, NATRUM CARBONICUM, ILEUM (SUIS), JEJUNUM (SUIS) STOMACH (SUIS), GLUTEN, AMARANTH, AVENA SATIVA, NATRUM SULPHURICUM, SARCOLACTICUM ACIDUM, TRITICUM REPENS, CORTISONE ACETICUM, GLYPHOSATE, SYCOTIC CO BACILLUSDeseret Biologicals, Inc.c34957b3-d2e8-4d28-b0eb-0e96cb7b83a62024-02-22WarningsExact identifier
unii: 45P3261C7T
Throat CareECHINACEA, ACONITUM NAP., APIS MEL., ARUM DRAC., BELLADONNA, BRYONIA, CAJUPUTUM, FERRUM PHOS., GLYCYRRHIZA, KALI BIC., LACHESIS, MENTA PIP., MERC. VIV., NAJA, NAT. CARB., NAT SULPHURICUM, NITRICUM AC., NUX VOM., PHOS., PHYTOLACCA, PULSATILLA, SPONGIA, STANNUM MET., STICTA, THUJA OCC., ULMUS FULV., VERBASCUMNewton Laboratories, Inc.105975ec-82ea-dbfb-e063-6394a90a4fd12024-02-01WarningsExact identifier
unii: 45P3261C7T
EsteemAMBRA GRISEA, LILIUM TIGRINUM, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, VISCUM ALBUM, THUJA OCCIDENTALIS, HYPOTHALAMUS SUIS, CUBEBA OFFICINALIS, AGNUS CASTUS, ANACARDIUM ORIENTALE, BARYTA IODATA, LAC CANINUM, LAC FELINUM, NAJA TRIPUDIANS, RHUS GLABRA, ROSA DAMASCENA, SABADILLA, AURUM METALLICUM, MAGNESIUM IODIDE, CARCINOSINDeseret Biologicals, Inc.b5e02000-1861-4477-a203-471ef845b1d22024-01-31WarningsExact identifier
unii: 45P3261C7T
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirst76131655-3a87-feac-e053-2991aa0a82a12024-01-28Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Throat CareECHINACEA, ACONITUM NAP., APIS MEL., ARUM DRAC., BELLADONNA, BRYONIA, CAJUPUTUM, FERRUM PHOS., GLYCYRRHIZA, KALI BIC., LACHESIS, MENTA PIP., MERC. VIV., NAJA, NAT. CARB., NAT SULPHURICUM, NITRICUM AC., NUX VOM., PHOS., PHYTOLACCA, PULSATILLA, SPONGIA, STANNUM MET., STICTA, THUJA OCC., ULMUS FULV., VERBASCUMNewton Laboratories, Inc.0fb69003-c66c-97ad-e063-6394a90a4c9b2024-01-24WarningsExact identifier
unii: 45P3261C7T
A01 CELLULAR RECHARGEACETICUM ACIDUM, ARNICA MONTANA, AVENA SATIVA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CEANOTHUS AMERICANUS, CERATOSTIGMA ILLMOTTIANUM, CHININUM ARSENICOSUM, CITRICUM ACIDUM, ENGLISH ELM, EUROPEAN HORNBEAM, EUROPEAN OLIVE, GENTIANELLA AMARELLA, HYDROFLUORICUM ACIDUM, JUGLANS REGIA, LACTICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SILICOFLUORICUM, NATRUM SULPHURICUM, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, SARCOLACTICUM ACIDUM, SOLIDAGO VIRGAUREAApex Energetics Inc.b932ebd3-afea-6a95-e053-2995a90a27352024-01-08WarningsExact identifier
unii: XF417D3PSL
A12 DTX-KIDNEYAPIS MELLIFICA, BERBERIS VULGARIS, BETULA PUBESCENS BARK, BETULA VERRUCOSA LEAF, BOS TAURUS KIDNEY, BOS TAURUS URINARY BLADDER, CITRICUM ACIDUM, CITRUS LIMONUM, FAGUS SYLVESTRIS FLOWER BUD, NATRUM MURIATICUM, PETROSELINUM SATIVUM, QUERCUS ROBUR FLOWER BUD, SINUSITISINUM, SOLIDAGO VIRGAUREAApex Energetics Inc.bf52e26f-aa27-87ca-e053-2995a90a23e72024-01-08WarningsExact identifier
unii: XF417D3PSL
A03 ULTRA ANTITOXALFALFA, AMERICAN GINSENG, APIS MELLIFICA, ASPARAGUS OFFICINALIS, AVENA SATIVA, BARYTA IODATA, BERBERIS VULGARIS, BRYONIA, CARDUUS MARIANUS, CHAMOMILLA, CHELIDONIUM MAJUS, CONIUM MACULATUM, FERRUM IODATUM, LAPIS ALBUS, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, PASSIFLORA INCARNATA, SCROPHULARIA NODOSA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, UVA URSIApex Energetics Inc.b945cb81-aee4-38e8-e053-2a95a90aa8df2024-01-08WarningsExact identifier
unii: 45P3261C7T
N03 EXCHEMALLIUM SATIVUM, ARSENICUM ALBUM, BENZOICUM ACIDUM, BERBERIS VULGARIS, BETULA VERRUCOSA, CALCAREA CARBONICA, CARBOLICUM ACIDUM, CHELIDONIUM MAJUS, CHLORINUM, CITRICUM ACIDUM, HISTAMINUM, ICHTHYOLUM, JUNIPERUS COMMUNIS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM BICARBONICUM, SODIUM HYPOCHLORITE, SOLIDAGO VIRGAUREA, SULPHURApex Energetics Inc.ba73a050-9a5d-1549-e053-2a95a90a62aa2024-01-08WarningsExact identifier
unii: XF417D3PSL
unii: 8MDF5V39QO
2eefaf21-d162-419b-95f8-ed67b3dc677d8f549d95-985b-f783-1ebb-ef57bd2ecb052023-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 2eefaf21-d162-419b-95f8-ed67b3dc677d
spl set id: 8f549d95-985b-f783-1ebb-ef57bd2ecb05
Sodium BicarbonateSODIUM BICARBONATEPharma Nobis, LLCe42f674b-1a70-6a3c-e053-2995a90afa722023-12-22WarningsExact identifier
unii: 8MDF5V39QO
HEB Extra Strength Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEH. E. Butt Grocery Company9e502bd0-8042-8674-e053-2995a90a3d152023-12-18WarningsExact identifier
unii: XF417D3PSL
unii: 8MDF5V39QO
Medis Sodium BicarbonateSODIUM BICARBONATEHumco Holding Group, Inc5da32469-58fc-14b1-e053-2a91aa0a74c42023-12-15WarningsExact identifier
unii: 8MDF5V39QO
ProgeniteAMMONIUM CARBONICUM, BARYTA MURIATICA, BORAX, CAULOPHYLLUM THALICTROIDES, NATRUM CARBONICUM, SABAL SERRULATA, SABINA, SULPHURICUM ACIDUM, THIOSINAMINUM, FOLLICULINUM, TUBA UTERINA SUIS, UTERUS SUIS, HYPOTHALAMUS (SUIS), THYROIDINUM (SUIS), AGNUS CASTUS, CONIUM MACULATUM, GRAPHITES, HYOSCYAMUS NIGER, SEPIA, SELENIUM METALLICUM, X-RAYDeseret Biologicals6051c9d5-36ef-4bfa-baab-9862c94805fb2023-12-12WarningsExact identifier
unii: 45P3261C7T
Sodium Bicarbonate AntacidSODIUM BICARBONATERugby Laboratoriese73b5871-4a87-4473-ab00-5e5395be017d2023-12-06WarningsExact identifier
unii: 8MDF5V39QO
INONALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATESato Pharmaceutical Co., Ltd.e86d9c57-c877-49f1-a405-95a9a226ccf32023-12-04WarningsExact identifier
unii: 8MDF5V39QO
TerrestristatALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), CEREBRUM SUIS, PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, COFFEA CRUDA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, RADIUM BROMATUM, CARCINOSIN, TARENTULA CUBENSIS, X-RAY, HOLMIUM METALLICUM, URANIUM NITRICUM.Energique, Inc.9bd83312-6872-4e39-b7ff-bbeb69015d802023-11-17WarningsExact identifier
unii: 45P3261C7T

Reported adverse events (FAERS/openFDA)#

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