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 |
|---|---|---|---|---|---|---|
| NARCAN | NALOXONE HYDROCHLORIDE NASAL | Sportpharm LLC | 3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f92 | 2026-04-24 | Warnings | F850569PQR |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE | Golden State Medical Supply, Inc. | 4f6e0056-b19d-0d0e-e063-6294a90a16e5 | 2026-04-24 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Buprenorphine and Naloxone | BUPRENORPHINE AND NALOXONE | Redpharm Drug | 5005a6c8-9a3b-a99a-e063-6294a90aac13 | 2026-04-22 | Warnings, Adverse reactions | ANDA212756 1010600 F850569PQR 56W8MW3EN1 |
| Buprenorphine and Naloxone | BUPRENORPHINE AND NALOXONE | Bryant Ranch Prepack | 63aaa6cc-8574-4990-8239-6fdeffce92c8 | 2026-04-16 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE | Unit Dose Solutions, Inc. | 4f979409-f9a2-d3a2-e063-6394a90accd0 | 2026-04-16 | Warnings, Adverse reactions | 56W8MW3EN1 |
| CLENPIQ | SODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACID | Ferring Pharmaceuticals Inc. | e95fff66-4ec0-4001-a727-33e66a5ec7d5 | 2026-04-15 | Warnings, Adverse reactions | XF417D3PSL |
| Buprenorphine and Naloxone | BUPRENORPHINE AND NALOXONE | Aveva Drug Delivery Systems Inc. | cb112448-49a1-4209-bcdb-7cfae6501f51 | 2026-04-07 | Warnings, Adverse reactions | ANDA212756 3215-6523-30 3215-6522-30 3215-6524-30 3215-6523-01 3215-6524-01 3215-6521-01 3215-6522-01 3215-6521-30 3215-6523 3215-6521 3215-6522 3215-6524 03215652201 1307056 1307061 1010604 1010600 4edfc0c8-bc4c-555f-e063-6294a90a8ca9 cb112448-49a1-4209-bcdb-7cfae6501f51 F850569PQR 56W8MW3EN1 |
| Sodium Citrate and Citric Acid | SODIUM CITRATE AND CITRIC ACID | Chartwell Governmental & Specialty RX, LLC | 58c24504-47de-487a-ab8d-18add155ea95 | 2026-04-07 | Adverse reactions | 1Q73Q2JULR |
| BUPRENORPHINE | BUPRENORPHINE | Bryant Ranch Prepack | cd0a90c6-32cc-4114-8573-86ac85503bdf | 2026-04-03 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Buprenorphine HCl and Naloxone HCl | BUPRENORPHINE AND NALOXONE | Bryant Ranch Prepack | 2aaad1a7-a0fd-4dd5-bb53-03afad8f10b9 | 2026-04-03 | Warnings, Adverse reactions | 56W8MW3EN1 |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | BluePoint Laboratories | 327004b0-560a-84d0-e063-6294a90aa743 | 2026-04-02 | Warnings | F850569PQR |
| Buprenorphine and Naloxone | BUPRENORPHINE AND NALOXONE | INGENUS PHARMACEUTICALS, LLC | 4951ec29-609b-4836-b0e4-0d9c1d6ae6fe | 2026-03-23 | Warnings, Adverse reactions | ANDA212756 1307056 1307061 1010604 1010600 F850569PQR 56W8MW3EN1 |
| Buprenorphine HCl | BUPRENORPHINE HCL | REMEDYREPACK INC. | 69a647c0-bc09-4ee2-aeb3-ef286caf25e5 | 2026-03-23 | Warnings, Adverse reactions | 56W8MW3EN1 |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | HF Acquisition Co. LLC. DBA HealthFirst | 4d66b96a-acbb-2292-e063-6294a90af788 | 2026-03-19 | Warnings, Adverse reactions | F850569PQR |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE | Clinical Solutions Wholesale, LLC | 99a5b62f-bc08-44f4-abb8-300520d2162a | 2026-03-06 | Warnings, Adverse reactions | 56W8MW3EN1 |
| BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE | Clinical Solutions Wholesale, LLC | 8f2b94dc-f42f-45d5-8274-9e748ec20ef0 | 2026-03-05 | Warnings, Adverse reactions | 56W8MW3EN1 |
| REZENOPY | NALOXONE HCL | Scienture LLC | 5bb502aa-014f-4a36-8972-42a9439168fe | 2026-03-03 | Warnings, Adverse reactions | F850569PQR |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE | Major Pharmaceuticals | c5fbec69-e7de-44a8-b9fa-0378ae61a9fe | 2026-03-03 | Warnings, Adverse reactions | 56W8MW3EN1 |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | Henry Schein, Inc | bd65e3fe-cd7a-4855-8f55-8cc3a0921ccc | 2026-03-02 | Warnings, Adverse reactions | F850569PQR |
| buprenorphine hydrochloride | BUPRENORPHINE HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | 442831cf-9636-433a-9a12-e9a8cd31f72a | 2026-02-28 | Warnings, Adverse reactions | 56W8MW3EN1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.