NDC 3215-6521-01 - 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
- 3215-6521
- Requested NDC
- 3215-6521-01
- Package NDCs from labels
- 3215-6521-01, 3215-6521-30
- 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 |
|---|---|---|---|---|---|---|
| 3215-6521-01 | Buprenorphine and Naloxone | 1 in 1 POUCH | FILM | 1 | 2 | |
| 3215-6521-30 | 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 |
|---|---|---|---|---|---|---|
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Amneal Pharmaceuticals LLC | 8091a73d-9ecd-4578-a57b-5d85a2c5a16a | 2026-08-25 | Warnings | F850569PQR |
| Smelling Salts | AMMONIA | Shenzhen Finona Information Technology Co., Ltd | 3874ec89-0f1d-87b9-e063-6394a90a300a | 2026-08-24 | Warnings | 5138Q19F1X |
| Smelling Salts | AMMONIA INHALANT, SMELLING SALTS | Hodayfa Abu Alkian | 524e002c-f509-9395-e063-6394a90acd9e | 2026-08-20 | Warnings | 5138Q19F1X |
| Smelling Salts | AMMONIA INHALANT, SMELLING SALTS | Shenzhen Leadtop E-commerce Co.,Ltd. | 558e8629-6a8d-198d-e063-6294a90ac5fc | 2026-08-19 | Warnings | 5138Q19F1X |
| Smelling Salt | AMMONIA | Shenzhen Jufeng Qisheng Technology Co., Ltd. | 44e1b2c1-f524-782c-e063-6394a90ad1e4 | 2026-08-18 | Warnings | 5138Q19F1X |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE | REMEDYREPACK INC. | 4124c4ad-ef62-4c95-8e57-0d843862ae71 | 2026-08-17 | Warnings, Adverse reactions | 56W8MW3EN1 |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE | REMEDYREPACK INC. | 43027750-d218-49e5-867f-c941736d2056 | 2026-08-17 | Warnings, Adverse reactions | 56W8MW3EN1 |
| NARCAN | NALOXONE HYDROCHLORIDE NASAL | Emergent Devices Inc. | a0ebc83d-2892-40de-bc0a-775ce90b30db | 2026-08-17 | Warnings | F850569PQR |
| Buprenorphine and Naloxone Sublingual Film | BUPRENORPHINE AND NALOXONE | Redpharm Drug | 58d2c995-c0cf-a007-e063-6394a90a3f77 | 2026-08-12 | Warnings, Adverse reactions | 1010604 56W8MW3EN1 |
| Adaptopath | ADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUM | Energetix Corporation | 41234598-0cb5-41c2-bfbe-1c15ee9bf502 | 2026-08-11 | Warnings | XF417D3PSL |
| Aller-Chord A | ALFALFA, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, BRYONIA (ALBA), CITRICUM ACIDUM, COUMARINUM, EUPHRASIA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, JUNIPERUS COMMUNIS, MUCOSA NASALIS SUIS, NATRUM SULPHURICUM, PHOSPHORUS, POTHOS FOETIDUS, PULSATILLA (VULGARIS), SOLIDAGO VIRGAUREA, SULPHUR, TANACETUM VULGARE, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE | Energetix Corporation | 09e89c92-112d-4320-9df5-b9f938bb9095 | 2026-08-11 | Warnings | XF417D3PSL |
| Hepatic-Tone | CARDUUS MARIANUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CITRICUM ACIDUM, CYSTEINUM, HEPAR SUIS, LEPTANDRA VIRGINICA, MAGNESIA MURIATICA, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, QUASSIA (AMARA), TARAXACUM OFFICINALE | Energetix Corporation | d5f61f13-7e9f-4e46-8ad8-0336f36288df | 2026-08-11 | Warnings | XF417D3PSL |
| Isopathic Phenolic Rings | HOMEOPATHIC LIQUID | Energetix Corporation | 98a7ca26-ccb7-43c7-bd65-892fcbacc882 | 2026-08-11 | Warnings | XF417D3PSL |
| Metabopath | ADENOSINUM CYCLOPHOSPHORICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, BERBERIS VULGARIS, CITRICUM ACIDUM, COENZYME A, DNA, FUMARICUM ACIDUM, GLYCYRRHIZA GLABRA, HEPAR SULPHURIS CALCAREUM, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MANGANUM ACETICUM, NADIDUM, NATRUM MURIATICUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PULSATILLA, PYRIDOXINUM HYDROCHLORICUM, RHAMNUS PURSHIANA, RIBOFLAVINUM, RNA, SILICEA, SUCCINICUM ACIDUM, SULPHUR, THIAMINUM HYDROCHLORICUM, | Energetix Corporation | 58bfe670-d308-45a2-8046-7897b6221452 | 2026-08-11 | Warnings | XF417D3PSL |
| buprenorphine and naloxone | BUPRENORPHINE AND NALOXONE | Hikma Pharmaceuticals USA Inc. | 713db2c6-0544-4633-b874-cfbeaf93db89 | 2026-07-26 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Xenleta | LEFAMULIN ACETATE | Meitheal Pharmaceuticals Inc. | eb972ea8-7502-422e-84bb-66cb8e93ca06 | 2026-07-22 | Warnings, Adverse reactions | XF417D3PSL |
| buprenorphine hydrochloride | BUPRENORPHINE HYDROCHLORIDE | Advagen Pharma Ltd | 699638dd-3a53-445f-a545-d0e6eabfe1c9 | 2026-07-17 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Buprenorphine HCl | BUPRENORPHINE HCL | REMEDYREPACK INC. | e1aac2bb-cb83-46cb-9a29-502a62010667 | 2026-07-17 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Buprenorphine | BUPRENORPHINE | REMEDYREPACK INC. | aa86a438-1ebf-4c08-bf27-38f1e81efb3a | 2026-07-07 | Warnings, Adverse reactions | 56W8MW3EN1 |
| buprenorphine hydrochloride | BUPRENORPHINE HYDROCHLORIDE | REMEDYREPACK INC. | 11686845-f5fd-4e96-8a4f-9b132bf48840 | 2026-07-07 | Warnings, Adverse reactions | 56W8MW3EN1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.