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 | Type |
|---|---|---|---|
| FENTORA - Cephalon, LLC | Cephalon, LLC | 2023-12-31 | HUMAN PRESCRIPTION DRUG LABEL |
| National Council for Prescription Drug Programs indexing - billing unit | National Council for Prescription Drug Programs | 2012-07-24 | Indexing - Billing Unit |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63459-548-04 | EA - Each | 63459-548 | 1888c9d2-5870-40eb-9882-5bfa40662b22 | 1 | 2012-07-24 |
| 63459-548-28 | EA - Each | 63459-548 | 5e01f3ae-f449-4a7f-a09f-50ab662fd4de | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| FENTANYL CITRATE | ACTIVE INGREDIENT | MUN5LYG46H | FENTORA (FENTANYL CITRATE) TABLET [CEPHALON, INC.] | 10 | |
| FENTANYL | ACTIVE MOIETY | UF599785JZ | FENTORA (FENTANYL CITRATE) TABLET [CEPHALON, INC.] | 10 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | FENTORA (FENTANYL CITRATE) TABLET [CEPHALON, INC.] | 10 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FENTORA (FENTANYL CITRATE) TABLET [CEPHALON, INC.] | 10 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | FENTORA (FENTANYL CITRATE) TABLET [CEPHALON, INC.] | 10 | |
| SODIUM BICARBONATE | INACTIVE INGREDIENT | 8MDF5V39QO | FENTORA (FENTANYL CITRATE) TABLET [CEPHALON, INC.] | 10 | |
| SODIUM CARBONATE | INACTIVE INGREDIENT | 45P3261C7T | FENTORA (FENTANYL CITRATE) TABLET [CEPHALON, INC.] | 10 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | FENTORA (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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Drug Mart Effervescent Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Discount Drug Mart, Inc | 8bc65603-1dbf-30ab-e053-2995a90a7c15 | 2024-11-13 | Warnings | XF417D3PSL 8MDF5V39QO |
| Best Choice Effervescent Antacid Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Valu Merchandisers Company | 8aab905b-5fe7-dddb-e053-2995a90a6c6f | 2024-11-13 | Warnings | XF417D3PSL 8MDF5V39QO |
| Publix Fast Relief Effervescent | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Publix Super Markets Inc. | 73051f16-2569-7394-e053-2991aa0a5359 | 2024-11-13 | Warnings | XF417D3PSL 8MDF5V39QO |
| Quality Choice Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Chain Drug Marketing Association | 70d265de-ff94-e0e4-e053-2a91aa0a962a | 2024-11-13 | Warnings | XF417D3PSL 8MDF5V39QO |
| Quality Choice Extra Strength Effervescent Antacid and Pain Relief | ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE | Chain Drug Marketing Association | 9f7d0c96-a561-a8a0-e053-2995a90a250b | 2024-11-13 | Warnings | XF417D3PSL 8MDF5V39QO |
| WinCo Foods Effervescent Antacid and Pain Relief | ASPIRIN, SODIUM BICARBONATE, CITRIC ACID TABLET | WinCo Foods, LLC | 0c8a755a-089f-477f-97e9-0dd6fdfbe99d | 2024-11-13 | Warnings | XF417D3PSL 8MDF5V39QO |
| Sodium Bicarbonate | SODIUM BICARBONATE | Cardinal Health 107, LLC | f7c88834-aa7c-4aaa-ab9b-0cbcd1f4da3f | 2024-11-07 | Warnings | 8MDF5V39QO |
| Sodium Bicarbonate | SODIUM BICARBONATE | Rising Pharma Holdings, Inc. | f5a90c33-f29d-4d4b-b5e6-0b3c2514ce3e | 2024-11-01 | Boxed warning, Warnings | 8MDF5V39QO |
| XS H2O Liquescence | VALERIANA OFFICINALIS, CITRICUM ACIDUM, POTASSIUM BITARTRATE, ALLIUM SATIVUM, ARTERIA SUIS, CEREBRUM SUIS, KIDNEY (SUIS) RAUWOLFIA SERPENTINA, ADRENOCORTICOTROPHIN | Nutritional Specialties, Inc. | 16a266cd-79cc-4f1d-839c-45183107e82c | 2024-10-31 | Warnings | XF417D3PSL |
| Spleenex VH | ARALIA QUINQUEFOLIA, GINKGO BILOBA, PANCREAS SUIS, SPLEEN (SUIS), STOMACH (SUIS), GERMANIUM SESQUIOXIDE, COBALTUM METALLICUM, NICCOLUM METALLICUM, ZINCUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALIC ACID, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOQUINONE, BARYTA CARBONICA, PHOSPHORICUM ACIDUM, ACONITICUM ACIDUM, CIS, MAGNESIUM GLUCONICUM DIHYDRICUM, NUX VOMICA, PHOSPHORUS | Energique, Inc. | 54e2c88e-2483-4c38-86e5-19e218e713ae | 2024-10-30 | Warnings | XF417D3PSL |
| Spleenex V | ARALIA QUINQUEFOLIA, POTASSIUM GLUCONATE, GINKGO BILOBA, MAGNESIUM GLUCONICUM DIHYDRICUM, PANCREAS SUIS, SPLEEN (SUIS), STOMACH (SUIS), GERMANIUM SESQUIOXIDE, CUPRUM METALLICUM, ZINCUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIA PHOSPHORICA, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOCHINONUM, ACONITICUM ACIDUM, CIS-, NATRUM OXALACETICUM | Energique, Inc. | effbaa07-239b-42f2-afd4-0eeeba7de1fd | 2024-10-30 | Warnings | XF417D3PSL |
| Omeprazole and Sodium Bicarbonate | OMEPRAZOLE AND SODIUM BICARBONATE | ScieGen Pharmaceuticals, Inc. | a107804e-b308-4e79-9447-07d93016f70f | 2024-10-24 | Warnings, Adverse reactions | 8MDF5V39QO |
| Progenite | AMMONIUM 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-RAY | Deseret Biologicals | dfc114e0-34d4-4ae4-bba8-a8a1b7ad6a24 | 2024-10-23 | Warnings | 45P3261C7T |
| OHTAS ISAN ANTACID | CALCIUM CARBONATE, SODIUM BICARBONATE | OHTA'S ISAN CO.,LTD. | 53380470-5748-6fa7-548e-7484ef204c0f | 2024-10-21 | Warnings | 8MDF5V39QO |
| OHTAS ISAN ANTACID | CALCIUM CARBONATE, SODIUM BICARBONATE | OHTA'S ISAN CO.,LTD. | 8723fe90-8402-4511-b6c6-b71cf98513e3 | 2024-10-21 | Warnings | 8MDF5V39QO |
| Elliotts B | SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE | Lukare Medical, LLC | 08036dbd-55b3-47b9-9890-000f253544f3 | 2024-10-16 | Warnings, Adverse reactions | 8MDF5V39QO |
| teruflex blood bag system with diversion blood sampling arm 70 ml cpda-1 | ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINE | Terumo Corporation | 86b3a329-c83f-4977-92f5-0e9dfe1872d7 | 2024-10-10 | Warnings | XF417D3PSL |
| Bio Co-Enzyme Phase | CARDUUS 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-da1501ffe853 | 2024-10-04 | Warnings | XF417D3PSL |
| Esteem | AMBRA GRISEA, LILIUM TIGRINUM, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, VISCUM ALBUM, THUJA OCCIDENTALIS, HYPOTHALAMUS SUIS, CUBEBA OFFICINALIS, AGNUS CASTUS, ANACARDIUM ORIENTALE, BARYTA IODATA, LAC CANINUM, NAJA TRIPUDIANS, RHUS GLABRA, ROSA DAMASCENA, SABADILLA, AURUM METALLICUM, LAC FELINUM, MAGNESIUM IODIDE, CARCINOSIN | Deseret Biologicals, Inc. | 2946e748-85a9-4398-b4b6-81aa0f3ebe69 | 2024-10-04 | Warnings | 45P3261C7T |
| TERUFLEX BLOOD with Diversion Blood Sampling Arm 70 mL CPDA-1 | ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINE | Terumo Corporation | 39f2e11c-5a31-469f-b725-d096c1674421 | 2024-10-03 | Warnings | XF417D3PSL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.