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 11 of 20 · 388 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Well at WalgreensSODIUM BICARBONATE, SODIUM CHLORIDEWalgreen Companycb5d3d9d-2481-4303-b6af-0002de8c90652025-01-31WarningsExact identifier
unii: 8MDF5V39QO
Sinus Wash PacketSODIUM BICARBONATE, SODIUM CHLORIDERITE AID CORPORATIONd5b44ae7-81e8-1413-e053-2995a90a59332025-01-31WarningsExact identifier
unii: 8MDF5V39QO
Sinus Wash Saline Refills MeijerSODIUM BICARBONATE, SODIUM CHLORIDEMeijer, Inc.dd7465fe-503a-4e34-e053-2995a90a27782025-01-31WarningsExact identifier
unii: 8MDF5V39QO
SinuCleanseSODIUM BICARBONATE, SODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.ff4df6c5-c85f-406a-89d7-8c2853fd5e102025-01-31WarningsExact identifier
unii: 8MDF5V39QO
CVSSODIUM BICARBONATE, SODIUM CHLORIDECVS Pharmacybccefef8-f92d-42fc-90fc-86644d1df6552025-01-31WarningsExact identifier
unii: 8MDF5V39QO
Well at WalgreensSODIUM BICARBONATE, SODIUM CHLORIDEWalgreen Companybcd336b4-9189-44d5-ae6d-81e535eff6b52025-01-31WarningsExact identifier
unii: 8MDF5V39QO
SinuCleanseSODIUM BICARBONATE, SODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.c33bf872-54aa-45e0-9e40-a6565a13f1982025-01-31WarningsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate 10 gr (650 mg)SODIUM BICARBONATECitraGen Pharmaceuticals Inc.650fa284-5829-588f-e053-2991aa0a9a0e2025-01-30WarningsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate 5 gr (325 mg)SODIUM BICARBONATECitraGen Pharmaceuticals Inc.68aadbd9-f1c6-8a23-e053-2991aa0afd962025-01-30WarningsExact identifier
unii: 8MDF5V39QO
Tummy UpsetCHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ALOE, ANGELICA SINENSIS RADIX, ANTIMONIUM , ARGENTUM NITRICUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CINCHONA OFFICINALIS, GRAPHITES, HYDRASTIS CANADENSIS, IPECACUANHA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MYRRHA, NATRUM CARBONICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, ZINGIBER OFFICINALE.Newton Laboratories, Inc.9dc2da0a-0b3a-548e-e053-2995a90abe6d2025-01-28WarningsExact identifier
unii: 45P3261C7T
Sodium BicarbonateSODIUM BICARBONATEWorld Perfumes Inca83544e4-ec09-1e95-e053-2995a90ab7b92025-01-15WarningsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate 10 grSODIUM BICARBONATEReliable 1 Laboratories LLC321a772c-c44c-3d4e-e054-00144ff8d46c2025-01-15WarningsExact identifier
unii: 8MDF5V39QO
Premixed saline packetsSODIUM CHLORIDE, SODIUM BICARBONATEShenzhen Kerui lntl Trading Co., Ltd0d11e07b-c137-6efc-e063-6394a90a6bba2025-01-09WarningsExact identifier
unii: 8MDF5V39QO
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAvPAKfe070e2e-3e72-fb84-e053-6294a90afd882025-01-09Adverse reactionsExact identifier
unii: XF417D3PSL
Caring Mill Bug Bite Relief WipesCARING MILL BUG BITE RELIEF WIPESShenzhen Shierjie Biological Engineering Co., LTD2a373589-aec3-b294-e063-6394a90a39f12025-01-08WarningsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirst9545d58c-1c49-79b3-e053-2995a90a9d402025-01-08Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
7.5% SODIUM BICARBONATE7.5% SODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirst9d4bbd21-f59c-7e9c-e053-2a95a90a08262025-01-08Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Fentanyl CitrateFENTANYL CITRATEFresenius Kabi USA, LLC38d0c14a-a0c1-44cc-a939-0304eb8037d62024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: MUN5LYG46H
EsteemAGNUS CASTUS, AMBRA GRISEA, ANACARDIUM ORIENTALE, AURUM METALLICUM, BARYTA IODATA, CANDIDA ALBICANS, CARCINOSIN, CUBEBA OFFICINALIS, HYPOTHALAMUS SUIS, LAC CANINUM, LILIUM TIGRINUM, LYCOPODIUM CLAVATUM, MAGNESIUM IODIDE, NAJA TRIPUDIANS, NATRUM CARBONICUM, RHUS GLABRA, ROSA DAMASCENA, SABADILLA, THUJA OCCIDENTALIS, VISCUM ALBUMDeseret Biologicals, Inc.f10cebe6-6ed1-45f7-80d4-f6c19fd8d0942024-12-30WarningsExact identifier
unii: 45P3261C7T
EcoDent Ultimate Essential Mouthcare Sparkling Clean MintSODIUM BICARBONATELotus Brands, Inc.4a95c8c1-db7c-4791-ac58-3eac216a01262024-12-18WarningsExact identifier
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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