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 |
|---|---|---|---|---|---|---|
| Glucoreg | ASCORBICUM ACIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SARCOLACTICUM ACIDUM, THIAMINUM HYDROCHLORICUM, DHEA (DEHYDROEPIANDROSTERONE), ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, ACETALDEHYDE, INSULINUM (SUIS), INSULINUM (HUMAN), HEPAR SUIS, PANCREAS SUIS, PHLORIDZINUM, ALLOXANUM, BERBERIS VULGARIS, CARCINOSIN, LYCOPODIUM CLAVATUM, MOMORDICA BALSAMINA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SYZYGIUM JAMBOLANUM, | Deseret Biologicals, Inc. | c77d0682-a000-4783-a91c-d4e205c34774 | 2024-04-29 | Warnings | XF417D3PSL |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | CVS Pharmacy, Inc | 840e017d-0142-4d0e-a80e-327ac44bc0c5 | 2024-04-24 | Warnings | F850569PQR |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Walgreen Co. | 3829826b-e48f-4e26-869f-6b9e4ee0a840 | 2024-04-24 | Warnings | F850569PQR |
| Naloxone Hydrochloride | NALOXONE | Amneal Pharmaceuticals NY LLC | 8779a073-dc6e-410a-9959-fd370f0079f9 | 2024-04-19 | Warnings | F850569PQR |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Mylan Institutional LLC | 7faaedb3-227b-408d-b772-6b326638b00e | 2024-04-12 | Warnings, Adverse reactions | F850569PQR |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Par Health USA, LLC | 3ae08e26-223b-4971-b2f1-f1e183a3f930 | 2024-04-11 | Warnings, Adverse reactions | F850569PQR |
| Naloxone Hydrochloride | NALXONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 1bef59b9-7d51-4f19-a054-44b8eb6c6398 | 2024-04-10 | Warnings, Adverse reactions | F850569PQR |
| Balanced Salt | SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE | B. Braun Medical Inc. | 74ab8883-0a5f-46b4-8998-9358f6fd4ef4 | 2024-03-13 | Warnings, Adverse reactions | 1Q73Q2JULR |
| naloxone hydrochloride | NALOXONE HYDROCHLORIDE | Lifestar Pharma LLC | ef647e2a-84e7-4e3e-942a-b6fc250141b6 | 2024-03-04 | Warnings, Adverse reactions | F850569PQR |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | c72a60fb-196d-3f02-e053-2995a90ad906 | 2024-02-22 | Warnings, Adverse reactions | F850569PQR |
| Narcan Naloxone HCL | NARCAN NALOXONE HCL | HF Acquisition Co LLC, DBA HealthFirst | 11d770b8-b768-ba3d-e063-6394a90a61a6 | 2024-02-20 | Warnings | F850569PQR |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 94ff1857-06da-7986-e053-2a95a90afb18 | 2024-02-19 | Warnings, Adverse reactions | F850569PQR |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | c90e2d85-ed94-2c00-e053-2a95a90ad2a0 | 2024-01-30 | Warnings, Adverse reactions | F850569PQR |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Actavis Pharma, Inc. | 49350f7e-d613-40a8-8941-a2ec30eafdf3 | 2024-01-30 | Warnings | F850569PQR |
| NALOXONE HCl | NALOXONE HCL | HF Acquisition Co LLC, DBA HealthFirst | f8fcda15-8ba6-e66a-e053-6294a90a385c | 2024-01-28 | Warnings, Adverse reactions | F850569PQR |
| NALOXONE HCI | NALOXONE HCI | HF Acquisition Co. LLC, DBA Health First | 73c1bad3-6ac3-8682-e053-2a91aa0a176a | 2024-01-27 | Warnings, Adverse reactions | F850569PQR |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | e65e03c1-9a66-b30b-e053-2995a90aeb73 | 2024-01-27 | Warnings, Adverse reactions | F850569PQR |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | HF Acquisition Co. LLC, DBA HealthFirst | 74fc593e-ed47-efae-e053-2991aa0a5997 | 2024-01-25 | Warnings, Adverse reactions | F850569PQR |
| BSS | BALANCED SALT SOLUTION | Alcon Laboratories, Inc. | 4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea | 2024-01-25 | Warnings, Adverse reactions | 1Q73Q2JULR |
| BUPRENORPHINE | BUPRENORPHINE | Clinical Solutions Wholesale, LLC | 2181e700-caa1-48c4-90ce-60fec053ba6a | 2024-01-09 | Warnings, Adverse reactions | 56W8MW3EN1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.