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 |
|---|---|---|---|---|---|---|
| Day and Night Vitals | ALLIUM SAT, ALOE, ARSENICUM ALB, BERBER VULG, CALC PHOS, CEANOTHUS, CHELIDONIUM MAJ, CHOLESTERINUM, CLEMATIS ERECTA, CONDURANGO, GAMBOGIA, HAMAMELIS, KALI BROM, KALI PHOS, LYCOPODIUM, NAT CARB, PASSIFLORA, SENNA, SILICEA, SOLIDAGO, SPIGELIA ANTH, SPONGIA, VERATRUM VIR | NET Remedies | d5ddba51-5f0c-4b06-8f87-3cd6faf64b79 | 2021-01-19 | Warnings | 45P3261C7T |
| Earth | AUR MET, ARG NIT, CAUSTICUM, CINCHONA, CONDURANGO, CEANOTHUS, EUPHRASIA, FUCUS, GALLICUM AC, IRIS VERS, NET CARB, NITRICUM AC, PHOSPHORUS. | NET Remedies | 06bfa185-71a2-4297-9a02-a9951a004bc5 | 2021-01-19 | Warnings | 45P3261C7T |
| GUNA BOWEL PLUS | ACTIVATED CHARCOAL - ALOE - ALUMINUM OXIDE - BRYONIA ALBA ROOT - CHELIDONIUM MAJUS - COLLINSONIA - FRANGULA ALNUS BARK - LYCOPODIUM CLAVATUM SPORE - POTASSIUM CARBONATE- RHUBARB - STRYCHNOS NUX VOMICA SEED - SILYBUM MARIANUM SEED - SKATOLE - SODIUM CARBONATE - SUS SCROFA PANCREAS - TARAXACUM OFFICINALE - THIAMINE - | Guna spa | b3aa4fd3-c87a-ccd2-e053-2995a90a46a9 | 2021-01-17 | Warnings | 45P3261C7T |
| Real Relief | APIS MELLIFICA, ARNICA MONTANA, BENZOICUM ACIDUM, CAUSTICUM, COLCHICUM AUTUMNALE, NATRUM CARBONICUM | GMP Laboratories of America, Inc. | b7a1ce34-a996-22cf-e053-2a95a90afa45 | 2020-12-29 | Warnings | 45P3261C7T |
| Intestia | ECHINACEA, IRIS VERSICOLOR, URTICA URENS, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, DIOSCOREA VILLOSA, I ODIUM, IRIS VERSICOLOR, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, PULSATILLA, RHUS TOXICODENDRON, PYROGENIUM | Newton Laboratories, Inc. | 9a132c99-7278-f667-e053-2a95a90a3d2b | 2020-12-04 | Warnings | 45P3261C7T |
| Lymphatic Drainer | ECHINACEA, SOLIDAGO, TARAXACUM, ASTERIAS, AUR. MET., BELLADONNA, BENZOICUM AC., BERBER. VULG., BRYONIA, CALC. CARB., CANTHARIS, CARDUUS MAR., CEANOTHUS, CHELIDONIUM MAJ., CHIONANTHUS, CINCHONA, DIOSCOREA, IRIS VERS., NAT. CARB., NUX VOM., PTELEA.. | Newton Laboratories, Inc. | 9a633bfa-188c-dd42-e053-2995a90ad3aa | 2020-12-04 | Warnings | 45P3261C7T |
| Edema | ELAPS CORALLINUS, APIS MEL., ARSENICUM ALB., CANTHARIS, CINCHONA, COLCHICUM, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, JUNIPERUS COM., LACHESIS, MERC. VIV., NAJA, NAT. CARB., NAT.SULPHURICUM, RHUS TOXICODENDRON, SAMBUCUS NIG., STROPHANTHUS HISPIDUS, THUJA OCC., VIPERA BERUS, ECHINACEA, LAPPA, SOLIDAGO, TARAXACUM, URTICA UR. | Newton Laboratories, Inc. | 98fbd4b0-43ac-098b-e053-2a95a90a6645 | 2020-12-03 | Warnings | 45P3261C7T |
| Appetite - Craving Control | CHAMOMILLA, PASSIFLORA, VALERIANA, ANACARDIUM, ANTIMON. CRUD., ARG. NIT., BERBER. VULG., BRYONIA, CHELIDONIUM MAJ., DIGITALIS, GRAPHITES, HUMULUS, IRIS VERS., KALI CARB., LYCOPODIUM, NAT. CARB., NAT. SULPHURICUM, NUX VOM., PULSATILLA, RHUS TOX., SCUTELLARIA, SEPIA, STRAMONIUM | Newton Laboratories, Inc. | 98cf5293-2a47-5e15-e053-2995a90a9c3b | 2020-12-02 | Warnings | 45P3261C7T |
| Connec-T | ECHINACEA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BERBERIS AQUIFOLIUM, CALCAREA FLUORICA, CAPSICUM ANNUUM, CARDUUS MARIANUS, CINCHONA OFFICINALIS, IODIUM, KALI CARBONICUM, LACHESIS MUTUS, MAGNESIA CARBONICA, MERCURIUS VIVUS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORUS, PHYTOLACCA DECANDRA, SECALE CORNUTUM, THYMUS SERPYLLUM, THUJA OCCIDENTALIS, THYROIDINUM, VERBASCUM THAPSUS. | Newton Laboratories, Inc. | 9a630923-1497-1fc8-e053-2995a90ad001 | 2020-12-02 | Warnings | 45P3261C7T |
| Distress-Mood-Sadness | ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGO | Newton Laboratories, Inc. | 98d0be75-9b50-1e15-e053-2995a90abf3b | 2020-12-02 | Warnings | 45P3261C7T |
| Distress-Mood-Sadness | ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGO | Newton Laboratories, Inc. | 98d08917-2f1b-4dc7-e053-2a95a90a1ce0 | 2020-12-02 | Warnings | 45P3261C7T |
| Blues - Mood - Emotions | ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGO | Newton Laboratories, Inc. | 79890e75-dfac-0262-e053-2a91aa0a5ce5 | 2020-11-24 | Warnings | 45P3261C7T |
| Blues - Mood - Emotions | ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGO | Newton Laboratories, Inc. | 798ab5a2-7464-8e9d-e053-2a91aa0acc98 | 2020-11-24 | Warnings | 45P3261C7T |
| Cold Hands - Feet | HISTAMINUM HYDROCHLORICUM,THYROIDINUM, ACONITUM NAP., ARSENICUM ALB., BRYONIA, CACTUS, CALC. FLUOR., CEANOTHUS, CINCHONA, CONVALLARIA, DIGITALIS, GELSEMIUM, GLONOINUM, HYDROCOYLE, KALI CARB., LACHESIS, NAJA, NAT CARB., NAT MUR., NUX VOM., PHOSPHORUS, PULLSATILLA, RHUS TOXICODENDRON, STROPHANTHUS HISPIDUS, SULPHUR, ECHINACEA | Newton Laboratories, Inc. | 7a2b4f28-2128-a8b2-e053-2a91aa0a2402 | 2020-11-24 | Warnings | 45P3261C7T |
| Good Sense Omeprazole and Sodium Bicarbonate | OMEPRAZOLE, SODIUM BICARBONATE | L. Perrigo Company | bcf32242-de17-4da1-b707-4ce26262eb78 | 2020-11-16 | Warnings | 8MDF5V39QO |
| CPDA-1 | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE | Fenwal, Inc. | ee831456-5962-4d5e-ad0c-69ab85860453 | 2020-06-03 | XF417D3PSL | |
| Renacidin | CITRIC ACID, GLUCONOLACTONE AND MAGNESIUM CARBONATE | United-Guardian, Inc. | 13a9bbba-db21-4cba-991c-5d8afaf2ed74 | 2019-12-17 | Warnings, Adverse reactions | XF417D3PSL |
| CPDA-1 | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE | Fenwal, Inc. | e41adb4e-06fb-4141-ba55-50b043f3c9da | 2019-11-19 | XF417D3PSL | |
| CPDA-1 | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE | Fenwal, Inc. | 14445dfd-6041-40cd-a043-3f4da6bcb9c1 | 2019-11-18 | XF417D3PSL | |
| CPDA-1 | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE | Fenwal, Inc. | 2557199a-5f60-49d8-b093-1e0700211243 | 2019-11-18 | XF417D3PSL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.