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 9 of 17 · 334 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepacka7da638f-f590-4577-bff9-15a91c6e79172025-07-29Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Smelling SaltsSMELLING SALTSShenzhen Weikeduo E-commerce Co., Ltd.377fa82a-dcbe-9ab6-e063-6394a90a63842025-07-18WarningsExact identifier
unii: 5138Q19F1X
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEProPharma Distribution3856ea66-29b8-8fc2-e063-6394a90ac33a2025-07-18Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: XF417D3PSL
EndocrinpathALFALFA, BORAGO OFFICINALIS, CALCAREA CARBONICA, CEANOTHUS AMERICANUS, CITRICUM ACIDUM, FUCUS VESICULOSUS, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, PANCREAS SUIS, PHYTOLACCA DECANDRA, PITUITARUM POSTERIUM (BOVINE), SARSAPARILLA (SMILAX REGELII), SILICEA, SYZYGIUM JAMBOLANUM, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE)Energetix Corporation70f84941-b8a1-48f4-9c05-554e554f00492025-07-11WarningsExact identifier
unii: XF417D3PSL
Gluvelop SMELLING SALTSSMELLING SALTSShenzhen Nanjun Technology Co., Ltd398c26ec-5eba-1202-e063-6294a90a76c92025-07-09WarningsExact identifier
unii: 5138Q19F1X
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEBelleview Biosciences LLC3245e0e5-5e7f-c3f7-e063-6394a90ac2582025-07-07Adverse reactionsExact identifier
unii: 1Q73Q2JULR
unii: XF417D3PSL
Summit Smelling SaltsSUMMIT SMELLING SALTSWashburn Ventures LLC36b6ed08-4a98-6b31-e063-6394a90a6fb72025-06-16WarningsExact identifier
unii: 5138Q19F1X
buprenorphine hydrochlorideBUPRENORPHINE HYDROCHLORIDEA-S Medication Solutionsc1398d85-d4bb-4426-8ecf-a50400910d812025-05-28Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: 1Q73Q2JULR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEEugia US LLC8bcf426a-b4fc-4f24-9ad0-fb26168a0b562025-05-14Warnings, Adverse reactionsExact identifier
unii: F850569PQR
ANTYZE Smelling SaltsSMELLING SALTSShenzhen Nanjun Technology Co., Ltd33e8773c-0bea-9640-e063-6394a90ae14b2025-04-29WarningsExact identifier
unii: 5138Q19F1X
TricitratesTRICITRATESChartwell RX, LLC2a80ea6b-6334-4c33-a35e-a5cb2939fbcb2025-04-28Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDKesin Pharma Corporation3140f8fe-0644-7561-e063-6394a90a2c282025-04-21Adverse reactionsExact identifier
unii: 1Q73Q2JULR
unii: XF417D3PSL
Bio Co Enzyme PhaseACONITICUM ACIDUM, CIS-, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ADRENALINUM, , ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, ASCORBICUM ACIDUM, BARIUM OXALSUCCINICUM, BETA VULGARIS, CERIUM OXALICUM, CITRICUM ACIDUM, CYSTEINUM, FUMARICUM ACIDUM, HEPAR SULPHURIS CALCAREUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM PHOSPHORICUM, NADIDUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PANTOTHENIC ACID, PROTEUS (MORGANI), PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM,Deseret Biologicals, Inc.6edee6eb-0ec9-4d2a-9dc9-dc2a6503a6db2025-04-08WarningsExact identifier
unii: XF417D3PSL
Buprenorphine HClBUPRENORPHINE HCLBryant Ranch Prepackd5a8c41e-413e-4d48-9739-d158e5681dd02025-03-28Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HydrochlorideBUPRENORPHINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.adc1167e-910e-4d7b-abdc-751d3df0c3dc2025-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: 1Q73Q2JULR
BuprenorphineBUPRENORPHINEClinical Solutions Wholesale, LLC9d976ee7-9509-49da-89fd-48d7e712697b2025-02-17Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HydrochlorideBUPRENORPHINE HYDROCHLORIDESomerset Therapeutics, LLC74e40c51-853b-4e7f-b3cb-a27af29e1cbf2025-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1

Reported adverse events (FAERS/openFDA)#

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