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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.