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 16 of 20 · 388 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Natrum carbonicumSODIUM CARBONATEBoiron8644adda-42ae-b595-e053-2991aa0ac78b2023-11-14Exact identifier
unii: 45P3261C7T
Natrum carbonicumSODIUM CARBONATEBoiron864460f9-db50-3e37-e053-2a91aa0ab03f2023-11-14Exact identifier
unii: 45P3261C7T
Natrum carbonicumSODIUM CARBONATEBoiron864414b8-957a-7580-e053-2a91aa0a231d2023-11-14Exact identifier
unii: 45P3261C7T
Natrum carbonicumSODIUM CARBONATEBoiron86448954-413c-b8af-e053-2991aa0a68ad2023-11-14Exact identifier
unii: 45P3261C7T
Natrum carbonicumSODIUM CARBONATEBoiron86441779-8449-5d05-e053-2991aa0a10c22023-11-14Exact identifier
unii: 45P3261C7T
Natrum carbonicumSODIUM CARBONATEBoiron87fddb6a-d890-78a5-e053-2a95a90ac2aa2023-11-14Exact identifier
unii: 45P3261C7T
Natrum carbonicumSODIUM CARBONATEBoiron81bf8b10-7c5f-11e6-8655-424c583030312023-11-14Exact identifier
unii: 45P3261C7T
Sodium BicarbonateSODIUM BICARBONATEA-S Medication Solutionsd89406d3-4356-4a8c-acc1-89efe1d270102023-11-14Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEMedical Purchasing Solutions, LLC09cf38c2-0b44-eca1-e063-6294a90a72d82023-11-10Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
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.99eb7b5d-926d-aa16-e053-2a95a90a08342023-11-07WarningsExact identifier
unii: 45P3261C7T
omeprazole sodium bicarbonateOMEPRAZOLE SODIUM BICARBONATECipla USA Inc.9cdde58a-ae8a-451f-92cf-cab178e4ba922023-11-01Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEAPNAR PHARMA LPe206c240-55c2-2d00-e053-2a95a90a17792023-10-21Boxed warning, WarningsExact identifier
unii: 8MDF5V39QO
MetabCALCAREA SULPHURICA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CEREBELLUM (SUIS), GALLBLADDER (BOVINE), HEART (BOVINE), HEPAR (BOVINE), HYPOTHALAMUS SUIS, INTESTINE (SUIS), KIDNEY (BOVINE), LUNG (BOVINE), MEDULLA OSSIS SUIS, PANCREAS SUIS, PINEAL GLAND (SUIS), RECTAL MUCOSA (SUIS), SPLEEN (BOVINE), STOMACH (SUIS), THYMUS (OVINE), THYROIDINUM (BOVINE), URINARY BLADDER (SUIS), PITUITARUM POSTERIUM (BOVINE), ACETYL COENZYME A,Nutritional Specialties, Inc.bbed9973-238f-47c5-9a50-ac0869a7eb3a2023-10-09WarningsExact identifier
unii: XF417D3PSL
Omeprazole/Sodium BicarbonateOMEPRAZOLEStrides Pharma Science Limitedcf6d293e-d70d-443e-8292-d693e93aab552023-09-21Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: XF417D3PSL
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sodium BicarbonateSODIUM BICARBONATEOMNIVIUM PHARMACEUTICALS LLC.aea54f8d-1cdd-4a5c-a2f7-7317ae4c8fbc2023-08-10Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Liverex IGINKGO BILOBA, FEL TAURI, GALLBLADDER (SUIS), HEPAR SUIS), THYROIDINUM (SUIS), GERMANIUM SESQUIOXIDE, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, MANGANUM METALLICUM, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOCHINONUM, ARSENICUM METALLICUM, SULPHUR, ACONITICUM ACIDUM, CIS, LYCOPODIUM CLAVATUM, NATRUM OXALACETICUM, PHOSPHORUSEnergique, Inc.1c23c489-0a43-4736-a30a-0ae02c09fb452023-07-21WarningsExact identifier
unii: XF417D3PSL
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEDr. Reddy's Laboratories Inc.,c6b5f808-4a49-1303-9711-badb022ecd702023-07-19WarningsExact identifier
unii: 8MDF5V39QO
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, PANCREATINUM, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI)Deseret Biologicals, Inc.2fe2d3c1-1829-4a33-be8e-2bad52546f362023-07-17WarningsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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