NDC 0591-3212-54 - Fentanyl
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
- 0591-3212
- Requested NDC
- 0591-3212-54
- Package NDCs from labels
- 0591-3212-54
- Manufacturer
- STAT Rx USA LLC | PSS World Medical Inc.
- Effective date
- 2012-01-30
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Fentanyl Transdermal System C-II Revised: August 2008 Rx only | STAT Rx USA LLC | PSS World Medical Inc. | 2012-01-30 | 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0591-3212-54 | EA - Each | 0591-3212 | e620a7e6-1cef-4d63-b384-2d04b68c0540 | 1 | 2012-07-24 |
| 0591-3212-72 | EA - Each | 0591-3212 | ebff54db-61a2-4f68-9d5a-3853b05e4de2 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| FENTANYL | ACTIVE INGREDIENT | UF599785JZ | FENTANYL PATCH, EXTENDED RELEASE [STAT RX USA LLC] | 4 | |
| FENTANYL | ACTIVE MOIETY | UF599785JZ | FENTANYL PATCH, EXTENDED RELEASE [STAT RX USA LLC] | 4 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | FENTANYL PATCH, EXTENDED RELEASE [STAT RX USA LLC] | 4 |
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.