NDC 0378-9124-16 - 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
- 0378-9124
- Requested NDC
- 0378-9124-16
- Package NDCs from labels
- 0378-9124-16, 0378-9124-98
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Effective date
- 2025-12-15
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| FENTANYL - Mylan Pharmaceuticals Inc. | Mylan Pharmaceuticals Inc. | 2025-12-15 | HUMAN PRESCRIPTION DRUG LABEL |
| Fentanyl - Lake Erie Medical DBA Quality Care Products LLC | Lake Erie Medical DBA Quality Care Products LLC | 2019-10-22 | HUMAN PRESCRIPTION DRUG LABEL |
| Fentanyl - Physicians Total Care, Inc. | Physicians Total Care, Inc. | 2009-12-16 | 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 Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0378-9124-16 | FENTANYL | 1 in 1 POUCH | PATCH | 1 | 27 | |
| 0378-9124-16 | FENTANYL | 72 h in 1 PATCH | PATCH | 72 | 27 | |
| 0378-9124-98 | FENTANYL | 5 in 1 CARTON | PATCH | 5 | 27 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-9124-16 | EA - Each | 0378-9124 | f642fe72-09eb-4ed4-8263-249306f8ca51 | 1 | 2012-07-24 |
| 0378-9124-98 | EA - Each | 0378-9124 | 9f18f012-f3bd-4078-ac89-99416e321909 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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.