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 18 of 20 · 388 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Omeprazole, Sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEGuardian Drug Companye5c6c2cf-fb3b-456a-a0a0-be396d6f83192022-11-08Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Natrum CarbonicumNATRUM CARBONICUMHahnemann Laboratories, INC.ecee3632-9ca1-6e93-e053-2a95a90afb582022-11-07Exact identifier
unii: 45P3261C7T
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTIONFenwal, Inc.d55cb701-9664-4931-8754-1a8cae68da062022-11-01Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) SOLUTIONFenwal, Inc.f9d7f1b4-7a77-44f9-8924-10b16008b49d2022-11-01Exact identifier
unii: XF417D3PSL
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD)Fenwal, Inc.4a08a9ec-46a5-4fcf-80ee-5c33f1a8b7462022-11-01Exact identifier
unii: XF417D3PSL
ReBoostSILVER NITRATE,EUPHORBIA RESINIFERA RESIN, CALCIUM SULFIDE, GOLDENSEAL, POTASSIUM DICHROMATE,LUFFA OPERCULATA FRUIT, SODIUM CARBONATE, ECHINACEA UNSPECIFIED, CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE AND PULSATILLA VULGARISMediNaturacb8a8d2a-d9d2-4a71-9279-c5641a9126c62022-07-19WarningsExact identifier
unii: 45P3261C7T
Bio Co-Enzyme PhaseBETA VULGARIS, 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.e8f6e2ec-ae2e-4bee-b9d3-5f3a2e3daf652022-05-09WarningsExact identifier
unii: XF417D3PSL
ACD Blood-Pack Units (PL 146 PLASTIC)ANTICOAGULANT CITRATE DEXTROSE (ACD)Fenwal, Inc.ba894daa-688e-4a9e-bd74-e71797f951bb2022-04-27Exact identifier
unii: XF417D3PSL
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.22805f0d-ba58-41ea-b245-19980abcda222022-02-11Exact identifier
unii: XF417D3PSL
Headek NasalBELLADONNA, GLONOINUM, COFFEA, NATRUM CARB, NATRUM MUR.Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics976b9c85-68c9-46a5-9012-53cb24683b032021-12-29WarningsExact identifier
unii: 45P3261C7T
Joette Calabrese Survivalist KitABROT ACON AGN AIL AMBR AMBRO AM-C ANT-C APIS ARN ARS AUR-A AUR BAPT BAR-C BELL BB BOTH BOV BROM CADM-S CALAD CALC CAMPH CARB-AC CARD-M CEAN CHEL CHININ-A CINA CHIN CIC COB COLCH CON CROT-H CROT-T CUPR DULC ELAPS EUP-PER FL-AC GALPH GRAPH GUNP HAM HEKLA HELL HEP HYDR-AC HYOS HYPER KALI-BR KALI-C KALI-I LATH LAUR LED LOB MERC-CY MERC MEZ MOSCH MUR-AC NAJA NAT-C NIT-AC NUX-M PYROG PH-AC PIC-AC PLB RHUS-T RUTA SAMB SANG SARR SEP STRAM SUL-AC TAB TERENT TER TEUCR VERAT VERAT-V VIPOHM PHARMA INC.1ac2a2c4-704e-4efa-aa44-acc71d300f702021-12-29WarningsExact identifier
unii: 45P3261C7T
Sodium BicarbonateSODIUM BICARBONATEInternational Medication Systems, Limited77698221-a01d-4568-a7bc-d3d4e982875d2021-12-15Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.d763511e-f1a7-4014-94b9-f7ad8f023ff42021-12-02Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.cf9f43a0-c750-4cf0-ac49-176ab2105aab2021-12-02Exact identifier
unii: XF417D3PSL
8.4% SODIUM BICARBONATE8.4% SODIUM BICARBONATEHF Acquisition Co. LLC, DBA HealthFirst74d8bb7a-9e7a-105f-e053-2a91aa0aec922021-05-03Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEMedical Purchasing Solutions, LLCbfc9c321-665c-ca97-e053-2995a90a79542021-04-12Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Candid- YADRENALINUM, CANDIDA ALBICANS, THYROIDINUM, TORULA CEREVISIAE, TRITICUM, USTILAGO MAIDIS, ANTIMON. CRUD, ARSENICUM ALB., BAPTISIA, BERBER. AQUI., BRYONIA, CALC. PHOS., CINCHONA, HELONIAS DIOICA, HYDRASTIS, IODIUM, IRIS VERSICOLOR, KALI CARB., LACHESIS, LYCOPODIUM, MERC. VIV., NAT.CARB., NAT. PHOS, NITRICUM AC., PHOSPHORUS, PODOPH. PELT, PULSATILLA, SEPIA, ECHINACEA, GINKGO, JUGLANS REGIA, LAPPA, THUJA OCC.Newton Laboratories, Inc.c68c9c20-3a07-16df-e053-2a95a90a0cbc2021-02-01WarningsExact identifier
unii: 45P3261C7T
Candid-YADRENALINUM, CANDIDA ALBICANS, THYROIDINUM, TORULA CEREVISIAE, TRITICUM, USTILAGO MAIDIS, ANTIMON. CRUD, ARSENICUM ALB., BAPTISIA, BERBER. AQUI., BRYONIA, CALC. PHOS., CINCHONA, HELONIAS DIOICA, HYDRASTIS, IODIUM, IRIS VERSICOLOR, KALI CARB., LACHESIS, LYCOPODIUM, MERC. VIV., NAT.CARB., NAT. PHOS, NITRICUM AC., PHOSPHORUS, PODOPH. PELT, PULSATILLA, SEPIA, ECHINACEA, GINKGO, JUGLANS REGIA, LAPPA, THUJA OCC.Newton Laboratories, Inc.c68ea9c3-f95c-dbcd-e053-2995a90a9aeb2021-02-01WarningsExact identifier
unii: 45P3261C7T
Candid-YADRENALINUM, CANDIDA ALBICANS, THYROIDINUM, TORULA CEREVISIAE, TRITICUM, USTILAGO MAIDIS, ANTIMON. CRUD, ARSENICUM ALB., BAPTISIA, BERBER. AQUI., BRYONIA, CALC. PHOS., CINCHONA, HELONIAS DIOICA, HYDRASTIS, IODIUM, IRIS VERSICOLOR, KALI CARB., LACHESIS, LYCOPODIUM, MERC. VIV., NAT.CARB., NAT. PHOS, NITRICUM AC., PHOSPHORUS, PODOPH. PELT, PULSATILLA, SEPIA, ECHINACEA, GINKGO, JUGLANS REGIA, LAPPA, THUJA OCC.Newton Laboratories, Inc.c6a37dbe-3092-5ecf-e053-2a95a90a7c392021-02-01WarningsExact identifier
unii: 45P3261C7T
AllergyALLIUM SAT, ANACARDIUM, APIS MEL, GAMBOGIA, MERC SOLUB, NAT CARB, NITRICUM AC, NUX VOM, PHOSPHORUS, PULSATILLA, SULPHURNet Remedies0b7129bf-c0de-496c-81f5-286d5ce8d82c2021-01-21WarningsExact identifier
unii: 45P3261C7T

Reported adverse events (FAERS/openFDA)#

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