NDC 0378-8765-16 - Buprenorphine and Naloxone
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
- 0378-8765
- Requested NDC
- 0378-8765-16
- Package NDCs from labels
- 0378-8765-16, 0378-8765-93
- Manufacturer
- Redpharm Drug
- Effective date
- 2026-02-21
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Buprenorphine and Naloxone - Redpharm Drug | Redpharm Drug | 2026-02-21 | HUMAN PRESCRIPTION DRUG LABEL |
| Buprenorphine and Naloxone - Mylan Pharmaceuticals Inc. | Mylan Pharmaceuticals Inc. | 2026-01-15 | HUMAN PRESCRIPTION DRUG LABEL |
| Buprenorphine and Naloxone - Mylan Pharmaceuticals Inc. | Mylan Pharmaceuticals Inc. | 2019-11-04 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0378-8765-16 | Buprenorphine and Naloxone | 1 in 1 POUCH | FILM | 1 | 12 | |
| 0378-8765-93 | Buprenorphine and Naloxone | 30 in 1 CARTON | FILM | 30 | 12 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-8765-16 | EA - Each | 0378-8765 | ad31cec3-e4e6-4186-9b80-385f396b5b72 | 1 | 2020-05-08 |
| 0378-8765-93 | EA - Each | 0378-8765 | d7283375-1f4c-48dd-bc33-bd107f2f6890 | 1 | 2020-05-08 |
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.