NDC 63459-508-01 - ACTIQ

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
63459-508
Requested NDC
63459-508-01
Package NDCs from labels
63459-508-01, 63459-508-30
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
ACTIQ - Cephalon, LLCCephalon, LLC2023-12-31HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63459-508ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, LLC]24Legacy NDC20240828_90b94524-f913-48b3-3771-7b2fcffd888a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63459-508-01EA - Each63459-508d164b103-e031-498d-9899-93686c19ac8612013-02-13
63459-508-30EA - Each63459-508028aee28-a7c5-4cf0-b384-48e9fadcae5d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENTANYL CITRATEACTIVE INGREDIENTMUN5LYG46HACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.]7
FENTANYLACTIVE MOIETYUF599785JZACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.]7
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.]7
DEXTRATESINACTIVE INGREDIENTG263MI44RUACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.]7
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.]7
SUCROSEINACTIVE INGREDIENTC151H8M554ACTIQ (FENTANYL CITRATE) LOZENGE [CEPHALON, INC.]7

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 9 · 174 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LactistatARSENICUM ALBUM, CALCAREA CARBONICA, COCCULUS INDICUS, GRAPHITES, HYDROFLUORICUM ACIDUM, LACHESIS MUTUS, LACTICUM ACIDUM, RHUS TOX, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, SACCHARUM OFFICINALEEnergique, Inc.8dcc4a3a-9f21-4a77-ae42-b2c8283a076a2024-10-28WarningsExact identifier
unii: C151H8M554
Grain and Seed AntigensBAMBOO, BARLEY, CORN, COTTON SEED, FLAX SEED (LINUM USITATISSIMUM), MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SAFFLOWER, SESAME, SORGHUM, SOY BEAN, SUGARCANE, SUNFLOWER (HELIANTHUS ANNUUS), WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHUREnergique, Inc.a028eaea-76ef-45db-80e1-d7b4a0655d5e2024-10-25WarningsExact identifier
unii: C151H8M554
teruflex blood bag system with diversion blood sampling arm 70 ml cpda-1ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation86b3a329-c83f-4977-92f5-0e9dfe1872d72024-10-10WarningsExact identifier
unii: XF417D3PSL
Bio Co-Enzyme PhaseCARDUUS MARIANUS, ASCORBICUM ACIDUM, CYSTEINUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CERIUM OXALICUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, NADIDUM, NATRUM PYRUVICUM, PANTOTHENIC ACID, SUCCINICUM ACIDUM, ADRENALINUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, HEPAR SULPHURIS CALCAREUM, SULPHUR, ACONITICUM ACIDUM, CIS-,Deseret Biologicals, Inc.afad858e-064f-454d-be78-da1501ffe8532024-10-04WarningsExact identifier
unii: XF417D3PSL
TERUFLEX BLOOD with Diversion Blood Sampling Arm 70 mL CPDA-1ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation39f2e11c-5a31-469f-b725-d096c16744212024-10-03WarningsExact identifier
unii: XF417D3PSL
Gut Brain SpectrumABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, HELIUM, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUMEnergique, Inc.cb1566a4-92d4-4f1a-9211-f0c538a83c272024-09-27WarningsExact identifier
unii: C151H8M554
PMS ReliefAGNUS CASTUS, AURUM SULPHURATUM, CANDIDA ALBICANS, CIMICIFUGA RACEMOSA, COCCULUS INDICUS, CONIUM MACULATUM, CYCLAMEN EUROPAEUM, ELAPS CORALLINUS, FOLLICULINUM, HYPOTHALAMUS SUIS, KALI CARBONICUM, LAC CANINUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, PULSATILLA (PRATENSIS), SACCHARUM OFFICINALE, STANNUM METALLICUM, THUJA OCCIDENTALIS, THYROIDINUM (BOVINE)Deseret Biologicals, Inc.f03d8463-0a6d-4577-8fba-9cba246d3d452024-09-23WarningsExact identifier
unii: C151H8M554
TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of BloodANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation02015040-9b71-4dbe-8f8d-e0d0951e8f932024-09-19WarningsExact identifier
unii: XF417D3PSL
FocusGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, IODIUM, PHOSPHORUS, SARCOLACTICUM ACID, SACCHARUM OFFICINALE, ADENOSINUM CYCLOPHOSPHORICUM, CEREBRUM SUIS, HYPOTHALAMUS SUIS, SILICEA, ADRENALINUM, AMBRA GRISEA, CARBONEUM SULPHURATUM, TARENTULA HISPANA, AETHUSA CYNAPIUM, BARYTA CARBONICA, HELLEBORUS NIGER, VERATRUM ALBUM, CANDIDA ALBICANS, HYOSCYAMUS NIGERDeseret Biologicals, Inc.e77857b8-be67-4041-8c8d-9772f17c6d062024-09-11WarningsExact identifier
unii: C151H8M554
PMS ReliefAGNUS CASTUS, CIMICIFUGA RACEMOSA, KALI CARBONICUM, LYCOPODIUM CLAVATUM, SACCHARUM OFFICINALE, THYROIDINUM (BOVINE), HYPOTHALAMUS SUIS, ARISTOLOCHIA CLEMATITIS, FOLLICULINUM, AURUM SULPHURATUM, CANDIDA ALBICANS, COCCULUS INDICUS, CONIUM MACULATUM, CYCLAMEN EUROPAEUM, ELAPS CORALLINUS, LAC CANINUM, LACHESIS MUTUS, MAGNESIA CARBONICA, PULSATILLA (PRATENSIS), STANNUM METALLICUMDeseret Biologicals, Inc.ca073beb-330d-406c-9bf5-196a89f3ab582024-09-11WarningsExact identifier
unii: C151H8M554
Quality Choice Effervescent Antacid and Pain Relief - Extra StrengthASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association1f926637-a61c-8eb7-e063-6394a90a65022024-08-13WarningsExact identifier
unii: XF417D3PSL
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAmerican Health Packaging58fa9952-c8ab-4ebb-a073-15cc45f4832a2024-07-16Adverse reactionsExact identifier
unii: XF417D3PSL
Sodium PhosphatesSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC ANHYDROUSAmerican Regent, Inc.dc0462ee-4486-418c-865f-e2a71bdb8e9e2024-06-06Warnings, Adverse reactionsExact identifier
unii: 22ADO53M6F
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d5dea47-5103-21a3-e053-2995a90aee782024-05-20WarningsExact identifier
unii: C151H8M554
IntimateNATRUM CARBONICUM, SACCHARUM OFFICINALE, LITHIUM CARBONICUM, PLACENTA TOTALIS SUIS, LAC CANINUM, ANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, GERMANIUM METALLICUM, HELLEBORUS NIGER, MAGNESIA OXYDATA, RHUS GLABRA, STRAMONIUM, THUJA OCCIDENTALIS, DNA (HUMAN), OXYTOCIN, HYDROGEN, NEON, LAC MATERNA HUMANUMDeseret Biologicals, Inc.ca0447c1-606e-443a-b789-7d65143fec282024-05-13WarningsExact identifier
unii: C151H8M554
REFL HSADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREAS SUIS, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI)Deseret Biologicals, Inc.83249aee-f58b-442d-9187-6de0cf070e4d2024-04-29WarningsExact identifier
unii: XF417D3PSL
GlucoregASCORBICUM ACIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SARCOLACTICUM ACIDUM, THIAMINUM HYDROCHLORICUM, DHEA (DEHYDROEPIANDROSTERONE), ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, ACETALDEHYDE, INSULINUM (SUIS), INSULINUM (HUMAN), HEPAR SUIS, PANCREAS SUIS, PHLORIDZINUM, ALLOXANUM, BERBERIS VULGARIS, CARCINOSIN, LYCOPODIUM CLAVATUM, MOMORDICA BALSAMINA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SYZYGIUM JAMBOLANUM,Deseret Biologicals, Inc.c77d0682-a000-4783-a91c-d4e205c347742024-04-29WarningsExact identifier
unii: XF417D3PSL
GlyregACETICUM ACIDUM, CACAO, MAGNESIA SULPHURICA, NATRUM SULPHURICUM, VERBASCUM THAPSUS, GLANDULA SUPRARENALIS SUIS, PANCREAS SUIS, CORTISONE ACETICUM, THYROIDINUM (SUIS), IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, RANUNCULUS BULBOSUS, SACCHARUM OFFICINALE, VANADIUM METALLICUM, ZINCUM METALLICUM, CHROMIUM ACIDUM, CULEX MUSCADeseret Biologicals, Inc28e670ca-ed35-4256-af20-74c25dc180992024-04-23WarningsExact identifier
unii: C151H8M554
HabitCHAMOMILLA, NATRUM PHOSPHORICUM, VALERIANA OFFICINALIS, PASSIFLORA INCARNATA, ARGENTUM NITRICUM, CALADIUM SEGUINUM, CINCHONA OFFICINALIS, MURIATICUM ACIDUM, SACCHARUM OFFICINALE, AVENA SATIVA, TABACUM, CEREBRUM SUIS, SEROTONIN (HYDROCHLORIDE), ARGEMONE MEXICANA, AGARICUS MUSCARIUS, ARSENICUM ALBUM, AURUM METALLICUM, IPECACUANHA, SEPIA, HYPOTHALAMUS (BOVINE), VIPERA BERUSDeseret Biologicals, Inc.3d00a305-e15d-4419-97bd-332421d4a1b02024-03-15WarningsExact identifier
unii: C151H8M554
Leaky Gut FormulaALFALFA, GLYCYRRHIZA GLABRA, ASTACUS FLUVIATILIS, BERBERIS AQUIFOLIUM, LAC DEFLORATUM, NATRUM CARBONICUM, SACCHARUM OFFICINALE, ALOE, FEL TAURI, PANCREAS SUIS, FRAGARIA VESCA, ANTIMONIUM CRUDUM, CARBO VEGETABILIS, EUPHORBIUM OFFICINARUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, ZINCUM METALLICUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS)Deseret Biologicals, Inc.7e3a254b-a43d-43a2-a777-0d0c0057e1312024-03-14WarningsExact identifier
unii: C151H8M554

Reported adverse events (FAERS/openFDA)#

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