NDC 3215-6523-01 - 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
- 3215-6523
- Requested NDC
- 3215-6523-01
- Package NDCs from labels
- 3215-6523-01, 3215-6523-30
- 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 |
|---|---|---|---|---|---|---|
| 3215-6523-01 | Buprenorphine and Naloxone | 1 in 1 POUCH | FILM | 1 | 2 | |
| 3215-6523-30 | 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 |
|---|---|---|---|---|---|---|
| Zubsolv | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | Orexo US, Inc. | 5f5cfcfe-d52b-49e6-8fe4-550477332dd2 | 2025-12-27 | Warnings, Adverse reactions | F850569PQR 56W8MW3EN1 |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | BPI Labs LLC | 5de44ee7-6525-4857-9a67-8882e96dbeb5 | 2025-12-26 | Warnings, Adverse reactions | F850569PQR |
| Buprenorphine HCl | BUPRENORPHINE HCL | Redpharm Drug | 301eaed5-8499-ad95-e063-6294a90a58f5 | 2025-12-23 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Suboxone | BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE | INDIVIOR INC. | 8a5edcf9-828c-4f97-b671-268ab13a8ecd | 2025-12-22 | Warnings, Adverse reactions | 1307056 1307061 1010604 1010600 F850569PQR 56W8MW3EN1 |
| Sterile Cord Blood Collection Unit (MSC128D) | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION | Maco Productions | 251fd4cb-4aa4-4473-9f89-968da856eb77 | 2025-12-18 | Warnings | 1Q73Q2JULR |
| Sterile Cord Blood Collection Unit (MSC127D) | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION | Maco Productions | 75a008b2-9666-4bfa-ab18-6d09b43b2215 | 2025-12-18 | Warnings | 1Q73Q2JULR |
| Buprenorphine Hydrochloride | BUPRENORPHINE HYDROCHLORIDE | Par Health USA, LLC | 34767dda-ce52-4f98-a45f-bb5cee0cd5e6 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | 56W8MW3EN1 |
| Pall Sterile Cord Blood Collection Unit | STERILE CORD BLOOD COLLECTION UNIT | Global Life Sciences Solutions USA LLC | aa9340b7-cc63-e17d-e053-2a95a90ad4d9 | 2025-12-18 | Warnings | 1Q73Q2JULR |
| HZ-Chord | BAPTISIA TINCTORIA, CEANOTHUS AMERICANUS, CITRICUM ACIDUM, ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, HYDROCOTYLE ASIATICA, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MEZEREUM, MORBILLINUM, NUX VOMICA, PALOONDO, PHYTOLACCA DECANDRA, SEPIA, THUJA OCCIDENTALIS, THYROIDINUM (BOVINE) | Energetix Corporation | 9685aec5-a65d-40fe-b5d7-2f13a69733bc | 2025-12-17 | Warnings | XF417D3PSL |
| Category V | IMMUNE SYSTEM BOOSTER | Vitality Works, Inc, | 0d3dd923-336c-4ccd-a344-ec49b2e80d10 | 2025-12-17 | Warnings | XF417D3PSL |
| STERILE CORD BLOOD COLLECTION UNIT (MSC123D) | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE | Maco Productions | e3b456ec-4578-485f-a696-8a343505f30b | 2025-12-16 | Warnings | 1Q73Q2JULR |
| Buprenorphine and Naloxone | BUPRENORPHINE AND NALOXONE | Redpharm Drug | 374530e2-3b2e-77d7-e063-6394a90a37c9 | 2025-12-11 | Warnings, Adverse reactions | 56W8MW3EN1 |
| FCS HP | EPINEPHRINE,GLUTAMICACID,MUCUNAPRURIENSSEED,NIACINAMIDE,SEROTONIN,UBIDECARENONE,CORTICOTROPIN,ADENOSINETRIPHOSPHATE,INSULINPORK,SUSSCROFAPARATHYROIDGLAND,SUSSCROFAPITUITARYGLAND,THIAMINEHYDROCHLORIDE,THYROID,ANHYDROUSCITRICACID,HERRINGSPERMDNA,SACCHAROMYCESCEREVISIAERNA,ANACARDIUMOCCIDENTALEFRUIT,ARSENICTRIOXIDE,ASPARTICACID,BARIUMCARBONATE,OYSTERSHELLCALCIUMCARBONATECRUDE,CLEMATISRECTAFLOWERINGTOP,LYCOPODIUMCLAVATUMSPORE,ANEMONEPULSATILLA,DATURASTRAMONIUM,SULFUR | Natural Creations, Inc. | ba8fed68-f27f-4651-adec-0994a5375887 | 2025-12-10 | Warnings | XF417D3PSL |
| FCS CP | CORTICOTROPIN,GLUTAMICACID,MUCUNAPURIENSSEED,SEROTONIN,EPINEPHRINE,NIACINAMIDE,UBIDECARENONE,ADENOSINETRIPHOSPHATE,INSULINPORK,SUSSCROFAPARATHYROIDGLAND,SUSSCROFAPITUITARYGLAND,THIAMINEHYDROCHLORIDE,THYROID,UNSPECIFIED,ANHYDROUSCITRICACID,HERRINGSPERMDNA,SACCHAROMYCESCEREVISIAERNA,ANACARDIUMOCCIDENTALEFRUIT,ARSENICTRIOXIDE,ASPARTICACID,BARIUMCARBONATE,OYSTERSHELLCALCIUMCARBONATE,CRUDE,CLEMATISRECTAFLOWERINGTOP,LYCOPODIUMCLAVATUMSPORE,ANEMONEPULSATILLA,DATURASTRAMONIUM,SULFUR | Natural Creations, Inc | cb69e9d6-62a6-4af0-8d2d-1e68b0830a20 | 2025-12-10 | Warnings | XF417D3PSL |
| PaxLyte | LEUCOVORIN, FOLIC ACID, LEVOMEFOLATE MAGNESIUM, FERROUS CYSTEINE GLYCINATE, 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, PHOSPHATIDYL SERINE, PYRIDOXAL 5-PHOSPHATE, FLAVIN ADENINE DINUCLEOTIDE, NADH, COBAMAMIDE, COCARBOXYLASE (THIAMINE PYROPHOSPHATE), MAGNESIUM ASCORBATE, ZINC ASCORBATE, MAGNESIUM L-THREONATE AND BETAINE CAPSULE | Jaymac Pharmaceuticals | f520b130-61b3-443e-aaf6-91e094e7a334 | 2025-12-08 | Warnings, Adverse reactions | 1Q73Q2JULR |
| Snap Labs Ammonia Inhalants | AMMONIA INHALANT | Brined LLC d/b/a Snap Labs | 453b0e9c-8676-99fa-e063-6394a90a88a1 | 2025-12-08 | Warnings | 5138Q19F1X |
| Snap Labs 20-Count Ammonia Inhalants | AMMONIA INHALANTS | Brined LLC d/b/a Snap Labs | 4575d816-b08f-13fb-e063-6294a90af3ba | 2025-12-08 | Warnings | 5138Q19F1X |
| Narcan | NALOXONE HYDROCHLORIDE | Emergent Devices Inc. | 724df050-5332-4d0a-9a5f-17bf08a547e1 | 2025-12-05 | Warnings, Adverse reactions | F850569PQR |
| ZIMHI | NALOXONE HYDROCHLORIDE | ZMI Pharma Inc. | 523c0909-bff6-4010-988a-53de18b7cb3f | 2025-12-04 | Warnings, Adverse reactions | F850569PQR |
| Alka-Seltzer Extra Strength | ANHYDROUS CITRIC ACID, SODIUM BICARBONATE, AND ASPIRIN | Bayer HealthCare LLC. | 49b73bd5-6465-05eb-e054-00144ff88e88 | 2025-12-04 | Warnings | XF417D3PSL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.