FDA.reportPublic FDA data

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 table
LabelManufacturerEffective dateType
Buprenorphine and Naloxone - Aveva Drug Delivery Systems Inc. | DifGen Pharmaceuticals LLCAveva Drug Delivery Systems Inc. | DifGen Pharmaceuticals LLC2026-04-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
3215-6522-01Buprenorphine and Naloxone1 in 1 POUCHFILM12
3215-6522-30Buprenorphine and Naloxone30 in 1 CARTONFILM302

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.

Matched openFDA labels page 14 of 17 · 334 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUPRENORPHINEBUPRENORPHINEClinical Solutions Wholesale, LLC325532f0-276f-4689-97d6-cda879b4c7582024-01-09Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEClinical Solutions Wholesale, LLC273b79ac-2c62-4407-9cd1-2a2964ef13ba2024-01-09Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
A01 CELLULAR RECHARGEACETICUM ACIDUM, ARNICA MONTANA, AVENA SATIVA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CEANOTHUS AMERICANUS, CERATOSTIGMA ILLMOTTIANUM, CHININUM ARSENICOSUM, CITRICUM ACIDUM, ENGLISH ELM, EUROPEAN HORNBEAM, EUROPEAN OLIVE, GENTIANELLA AMARELLA, HYDROFLUORICUM ACIDUM, JUGLANS REGIA, LACTICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SILICOFLUORICUM, NATRUM SULPHURICUM, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, SARCOLACTICUM ACIDUM, SOLIDAGO VIRGAUREAApex Energetics Inc.b932ebd3-afea-6a95-e053-2995a90a27352024-01-08WarningsExact identifier
unii: XF417D3PSL
A12 DTX-KIDNEYAPIS MELLIFICA, BERBERIS VULGARIS, BETULA PUBESCENS BARK, BETULA VERRUCOSA LEAF, BOS TAURUS KIDNEY, BOS TAURUS URINARY BLADDER, CITRICUM ACIDUM, CITRUS LIMONUM, FAGUS SYLVESTRIS FLOWER BUD, NATRUM MURIATICUM, PETROSELINUM SATIVUM, QUERCUS ROBUR FLOWER BUD, SINUSITISINUM, SOLIDAGO VIRGAUREAApex Energetics Inc.bf52e26f-aa27-87ca-e053-2995a90a23e72024-01-08WarningsExact identifier
unii: XF417D3PSL
Buprenorphine HClBUPRENORPHINE HCLClinical Solutions Wholesale, LLC3a7418a2-bd6e-4082-b0fe-a5498e7b944a2024-01-08Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
N03 EXCHEMALLIUM SATIVUM, ARSENICUM ALBUM, BENZOICUM ACIDUM, BERBERIS VULGARIS, BETULA VERRUCOSA, CALCAREA CARBONICA, CARBOLICUM ACIDUM, CHELIDONIUM MAJUS, CHLORINUM, CITRICUM ACIDUM, HISTAMINUM, ICHTHYOLUM, JUNIPERUS COMMUNIS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM BICARBONICUM, SODIUM HYPOCHLORITE, SOLIDAGO VIRGAUREA, SULPHURApex Energetics Inc.ba73a050-9a5d-1549-e053-2a95a90a62aa2024-01-08WarningsExact identifier
unii: XF417D3PSL
Naloxone HydrochlorideNALOXONE HYDROCHLORIDETeva Pharmaceuticals, Inc.3a73ee4b-c2a4-496f-be90-9f78c80460622024-01-01WarningsExact identifier
unii: F850569PQR
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEA-S Medication Solutions46f27d04-d4d2-4ef1-9cc5-4d58f4056f062023-12-27WarningsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDESomerset Therapeutics, LLCb59ee3cc-9604-4abc-81be-897e2f42aa672023-12-19Warnings, Adverse reactionsExact identifier
unii: F850569PQR
HEB Extra Strength Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEH. E. Butt Grocery Company9e502bd0-8042-8674-e053-2995a90a3d152023-12-18WarningsExact identifier
unii: XF417D3PSL
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.28488c7b-cf6a-4a03-916f-cc66b3afdc572023-12-14Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDE NASALA-S Medication Solutions4517afa1-4b17-4a15-b91b-65b18bd0558f2023-11-24Warnings, Adverse reactionsExact identifier
unii: F850569PQR
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEBryant Ranch Prepack53457b0d-3462-489e-8cf5-7cdc2ecffb482023-11-16Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
NARCAN NALOXONE HCINARCAN NALOXONE HCIHF Acquisition Co LLC, DBA HealthFirst784a0e98-c2d6-f845-e053-2991aa0ac4b42023-10-10Warnings, Adverse reactionsExact identifier
unii: F850569PQR
MetabCALCAREA SULPHURICA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CEREBELLUM (SUIS), GALLBLADDER (BOVINE), HEART (BOVINE), HEPAR (BOVINE), HYPOTHALAMUS SUIS, INTESTINE (SUIS), KIDNEY (BOVINE), LUNG (BOVINE), MEDULLA OSSIS SUIS, PANCREAS SUIS, PINEAL GLAND (SUIS), RECTAL MUCOSA (SUIS), SPLEEN (BOVINE), STOMACH (SUIS), THYMUS (OVINE), THYROIDINUM (BOVINE), URINARY BLADDER (SUIS), PITUITARUM POSTERIUM (BOVINE), ACETYL COENZYME A,Nutritional Specialties, Inc.bbed9973-238f-47c5-9a50-ac0869a7eb3a2023-10-09WarningsExact identifier
unii: XF417D3PSL
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEA-S Medication Solutions0b3b5214-6f91-4bba-82d6-d57b16845df52023-10-01Warnings, Adverse reactionsExact identifier
unii: F850569PQR
NARCANNALOXONE HYDROCHLORIDEA-S Medication Solutions139c30b9-5600-48f5-8610-0cacd27823982023-09-28Warnings, Adverse reactionsExact identifier
unii: F850569PQR
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: XF417D3PSL
AnubisMedGLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACIDANUBIS COSMETICS SLeca95dde-cb57-2ab6-e053-2995a90af84f2023-09-05WarningsExact identifier
unii: 5138Q19F1X
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: H3R47K3TBD

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.