NDC 3215-6522-01 - 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
- 3215-6522
- Requested NDC
- 3215-6522-01
- Package NDCs from labels
- 3215-6522-01, 3215-6522-30
- Manufacturer
- Aveva Drug Delivery Systems Inc. | DifGen Pharmaceuticals LLC
- Effective date
- 2026-04-07
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Buprenorphine and Naloxone - Aveva Drug Delivery Systems Inc. | DifGen Pharmaceuticals LLC | Aveva Drug Delivery Systems Inc. | DifGen Pharmaceuticals LLC | 2026-04-07 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 3215-6522-01 | Buprenorphine and Naloxone | 1 in 1 POUCH | FILM | 1 | 2 | |
| 3215-6522-30 | Buprenorphine and Naloxone | 30 in 1 CARTON | FILM | 30 | 2 |
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 |
|---|---|---|---|---|---|---|
| CPDA-1 | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE | Fenwal, Inc. | ee831456-5962-4d5e-ad0c-69ab85860453 | 2020-06-03 | XF417D3PSL | |
| Naloxone Hydrochloride | NALXONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 8cc25cf1-008c-4808-baec-49f35a887fae | 2020-03-20 | Warnings, Adverse reactions | F850569PQR |
| Renacidin | CITRIC ACID, GLUCONOLACTONE AND MAGNESIUM CARBONATE | United-Guardian, Inc. | 13a9bbba-db21-4cba-991c-5d8afaf2ed74 | 2019-12-17 | Warnings, Adverse reactions | XF417D3PSL |
| CPDA-1 | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE | Fenwal, Inc. | e41adb4e-06fb-4141-ba55-50b043f3c9da | 2019-11-19 | XF417D3PSL | |
| CPDA-1 | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE | Fenwal, Inc. | 14445dfd-6041-40cd-a043-3f4da6bcb9c1 | 2019-11-18 | XF417D3PSL | |
| CPDA-1 | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE | Fenwal, Inc. | 2557199a-5f60-49d8-b093-1e0700211243 | 2019-11-18 | XF417D3PSL | |
| CPDA-1 | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE | Fenwal, Inc. | 794f724c-87f0-49c1-9b26-c9e491978313 | 2019-11-18 | XF417D3PSL | |
| CPDA-1 | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE | Fenwal, Inc. | 5c7d3287-883a-459b-9214-074a583c8a59 | 2019-11-18 | XF417D3PSL | |
| CPDA-1 | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE | Fenwal, Inc. | 448a1dc5-7a98-4b2f-82af-4b92de05cfc3 | 2019-11-18 | XF417D3PSL | |
| Ammonia Inhalants | AMMONIA INHALANTS | James Alexander Corporation | b741afa6-e56c-4fbb-ada0-80b80aef72a7 | 2019-01-31 | Warnings | 5138Q19F1X |
| pentazocine and naloxone | PENTAZOCINE AND NALOXONE | Sun Pharmaceutical Industries, Inc. | 41ebdaaf-3bbc-419f-b996-0341efc14623 | 2018-07-31 | Boxed warning, Warnings, Adverse reactions | F850569PQR |
| Additox | TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM | BioActive Nutritional, Inc. | 319ee2fe-58e3-495e-bf0d-df201f6fbb1c | 2018-07-18 | Warnings | 1Q73Q2JULR |
| First Aid Only Ammonia Inhalants | AMMONIA INHALANTS | Acme United Corporation | 6595a2a5-f2d7-85cf-e053-2991aa0a9b52 | 2018-02-19 | Warnings | 5138Q19F1X |
| CPDA-1 | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE | Fenwal, Inc. | 051f7347-5a76-4664-8fe2-e61b3dfcb0e4 | 2014-08-27 | XF417D3PSL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.