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 |
|---|---|---|---|---|---|---|
| Bestmade Natural Products Sodium Bicarbonate (Nat Bicarb) | SODIUM BICARBONATE | Bestmade Natural Products | 2fad1d83-3c64-f1b3-e063-6294a90aa3e5 | 2025-05-26 | Warnings | 8MDF5V39QO |
| Mannitol | MANNITOL | Henry Schein, Inc. | e2444db1-9dfe-451f-a33c-9b00786464d2 | 2025-05-20 | Warnings, Adverse reactions | 3OWL53L36A |
| Sinus Wash Packet | SODIUM BICARBONATE, SODIUM CHLORIDE | BETTER LIVING BRANDS LLC | 33ee7b77-0871-4df8-e063-6394a90ac479 | 2025-04-29 | Warnings | 8MDF5V39QO |
| Sodium Citrate and Citric Acid | SODIUM CITRATE AND CITRIC ACID | Kesin Pharma Corporation | 3140f8fe-0644-7561-e063-6394a90a2c28 | 2025-04-21 | Adverse reactions | XF417D3PSL |
| Bio Co Enzyme Phase | ACONITICUM ACIDUM, CIS-, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ADRENALINUM, , ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, ASCORBICUM ACIDUM, BARIUM OXALSUCCINICUM, BETA VULGARIS, CERIUM OXALICUM, CITRICUM ACIDUM, CYSTEINUM, FUMARICUM ACIDUM, HEPAR SULPHURIS CALCAREUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM PHOSPHORICUM, NADIDUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PANTOTHENIC ACID, PROTEUS (MORGANI), PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, | Deseret Biologicals, Inc. | 6edee6eb-0ec9-4d2a-9dc9-dc2a6503a6db | 2025-04-08 | Warnings | XF417D3PSL |
| Alka-Seltzer Heartburn Relief Lemon Lime | ANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED) | Bayer Healthcare LLC | cc21af24-9a5b-6831-e053-2a95a90a0af4 | 2025-04-01 | Warnings | 8MDF5V39QO |
| Hypothaltem | EUPATORIUM PERFOLIATUM, BERBERIS VULGARIS, MENTHA PULEGIUM, MOSCHUS, BENZINUM, SEPIA, BARYTA CARBONICA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, THYROIDINUM (SUIS), PYRIDOXINUM HYDROCHLORICUM, GELSEMIUM SEMPERVIRENS, NATRUM CARBONICUM, NUX VOMICA, STAPHYSAGRIA | Nucleic Products, LLC | b95050f2-f40d-4e84-8752-4d7ad75390c9 | 2025-03-20 | Warnings | 45P3261C7T |
| Bestmade Natural Products Restful Legs Support | CALCAREA PHOSPHORICA, ACONITE NAP, ANACARDIUM ORI, ARGENTUM NIT, ARSENIC ALB, AURUM MUR, CHAMOMILLA, DUBOISIA, GELSEMIUM, IGNATIA, KALI BROM, LACHESIS MUTUS, LYCOPODIUM, MAG MUR, MOSCHUS, NAT CARB, NAT SULPH, PHOSPHORIC ACID, RAUWOLFIA SERP | Bestmade Natural Products | 304b48ac-c4b8-a5c0-e063-6394a90a07b6 | 2025-03-14 | Warnings | 45P3261C7T |
| Alka-Seltzer Heartburn Relief Extra Strength | ANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED) | Bayer Healthcare LLC | dc1641f8-54c2-0d86-e053-2995a90a1dce | 2025-03-11 | Warnings | 8MDF5V39QO |
| Bestmade Natural Products Nat Carb | NATRUM CARBONICUM | Bestmade Natural Products | 2fa9c941-37c0-0b76-e063-6394a90af79e | 2025-03-06 | Warnings | 45P3261C7T |
| Acid Reducer Powder | OMEPRAZOLE AND SODIUM BICARBONATE | Dr. Reddy's Laboratories Inc., | 6f8452f8-8c2c-6700-a11d-1531023056c5 | 2025-03-03 | Warnings | 8MDF5V39QO |
| Bestmade Natural Products BM212 | ARS ALB, KALI PHOS, NAT CARB, NITRIC ACID | Bestmade Natural Products | 2f37416e-b3af-f980-e063-6294a90a6be1 | 2025-02-28 | Warnings | 45P3261C7T |
| Stress-Tension | CHAMOMILLA, HYPERICUM PERFORATUM, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, AURUM METALLICUM, BAPTISIA, BRYONIA, CHELIDONIUM MAJUS, CIMICIFUGA RACEMOSA, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, LILIUM TIGRINUM, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PICRICUM ACIDUM, PLUMBUM METALLICUM, SEPIA, STAPHYSAGRIA, STRAMONIUM, THUJA OCCIDENTALIS, ZINCUM METALLICUM. | Newton Laboratories, Inc. | 9d22bedb-9f9d-8421-e053-2a95a90acf4a | 2025-02-10 | Warnings | 45P3261C7T |
| Stress-Tension | CHAMOMILLA, HYPERICUM PERFORATUM, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, AURUM METALLICUM, BAPTISIA, BRYONIA, CHELIDONIUM MAJUS, CIMICIFUGA RACEMOSA, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, LILIUM TIGRINUM, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PICRICUM ACIDUM, PLUMBUM METALLICUM, SEPIA, STAPHYSAGRIA, STRAMONIUM, THUJA OCCIDENTALIS, ZINCUM METALLICUM. | Newton Laboratories, Inc. | 9d23e5da-4806-8ccc-e053-2995a90a1901 | 2025-02-10 | Warnings | 45P3261C7T |
| Bestmade Natural Products BM118 | ANACARDIUM ORI, ARSENIC ALB, AURUM MUR, KALI BROM, LYCOPODIUM, NATRUM CARB, NATRUM SULPH, PHOSPHORIC ACID | Bestmade Natural Products | 2d90b08b-b65d-7d11-e063-6294a90a5092 | 2025-02-07 | Warnings | 45P3261C7T |
| Lymphatic Care | 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. | 9c3507de-1def-4019-e053-2a95a90a1475 | 2025-02-07 | Warnings | 45P3261C7T |
| Lymphatic Care | 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. | 9c36201a-2153-0600-e053-2995a90a6bbf | 2025-02-07 | Warnings | 45P3261C7T |
| Appetite - Craving Control | ANACARDIUM ORIENTALE, ANTIMON.CRUD., ARG. NIT., BERBER. VULG., BRYONIA, CHELIDONIUM MAJUS, DIGITALIS, GRAPHITES, HUMULUS,IRIS VERSICOLOR, KALI CARB., LYCOPODIUM, NAT. CARB.,NAT. SULPHURICUM, NUX VOM., PULSATILLA, RHUS. TOXICODENDRON, SCUTELLARIA LATERIFLORA, SEPIA,STRAMONIUM, CHAMOMILLA, PASSIFLORA, VALERIANA. | Newton Laboratories, Inc. | 7964f0f7-7774-fac6-e053-2a91aa0a3e4a | 2025-02-06 | Warnings | 45P3261C7T |
| Tummy Upset | CHAMOMILLA, 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. | 9dc307a2-4aa1-b02a-e053-2995a90a1788 | 2025-02-06 | Warnings | 45P3261C7T |
| Appetite - Craving Control | ANACARDIUM ORIENTALE, ANTIMON.CRUD., ARG. NIT., BERBER. VULG., BRYONIA, CHELIDONIUM MAJUS, DIGITALIS, GRAPHITES, HUMULUS,IRIS VERSICOLOR, KALI CARB., LYCOPODIUM, NAT. CARB.,NAT. SULPHURICUM, NUX VOM., PULSATILLA, RHUS. TOXICODENDRON, SCUTELLARIA LATERIFLORA, SEPIA,STRAMONIUM, CHAMOMILLA, PASSIFLORA, VALERIANA. | Newton Laboratories, Inc. | 79655acc-f059-e509-e053-2a91aa0ac488 | 2025-02-06 | Warnings | 45P3261C7T |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.