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 16 of 17 · 334 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CitriPlusJUGLANS REGIA WHOLE AND ANHYDROUS CITRIC ACIDPEKANA Natuheilmittel GmbH11db1b5b-2959-42c4-a059-25c9519330042023-01-11WarningsExact identifier
unii: XF417D3PSL
GlucoregASCORBICUM ACIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SARCOLACTICUM ACIDUM, THIAMINUM HYDROCHLORICUM, DHEA (DEHYDROEPIANDROSTERONE), PHLORIDZINUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, ACETALDEHYDE, INSULINUM (SUIS), INSULINUM (HUMAN), HEPAR SUIS, PANCREAS SUIS, PHLORIDZINUM, BARYTA OXALICA, ALLOXANUM, BERBERIS VULGARIS, CARCINOSIN, LYCOPODIUM CLAVATUM, MOMORDICA BALSAMINA, PHOSPHORICUM ACIDUM, PHOSPHORUS,Deseret Biologicals, Inc.5117f980-95b8-4fc8-9425-8f6f056394372022-12-29WarningsExact identifier
unii: XF417D3PSL
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co. LLC, DBA HealthFirst74fcd243-94b3-ec77-e053-2991aa0a229c2022-12-09Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTIONFenwal, Inc.d55cb701-9664-4931-8754-1a8cae68da062022-11-01Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) SOLUTIONFenwal, Inc.f9d7f1b4-7a77-44f9-8924-10b16008b49d2022-11-01Exact identifier
unii: XF417D3PSL
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD)Fenwal, Inc.4a08a9ec-46a5-4fcf-80ee-5c33f1a8b7462022-11-01Exact identifier
unii: XF417D3PSL
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEProficient Rx LP8d529b4c-85fd-4e50-9443-9080825307bf2022-10-01Warnings, Adverse reactionsExact identifier
unii: F850569PQR
NarcanNALOXONE HYDROCHLORIDEProficient Rx LP76b5a1ce-e601-457c-ab35-43533bba43942022-08-01Warnings, Adverse reactionsExact identifier
unii: F850569PQR
AddiclenzBETA VULGARIS, BOLDO, 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, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: 1Q73Q2JULR
Bio Co-Enzyme PhaseBETA VULGARIS, ASCORBICUM ACIDUM, CYSTEINUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CERIUM OXALICUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, NADIDUM, NATRUM PYRUVICUM, PANTOTHENIC ACID, SUCCINICUM ACIDUM, ADRENALINUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, HEPAR SULPHURIS CALCAREUM, SULPHUR, ACONITICUM ACIDUM, CIS-,Deseret Biologicals, Inc.e8f6e2ec-ae2e-4bee-b9d3-5f3a2e3daf652022-05-09WarningsExact identifier
unii: XF417D3PSL
ACD Blood-Pack Units (PL 146 PLASTIC)ANTICOAGULANT CITRATE DEXTROSE (ACD)Fenwal, Inc.ba894daa-688e-4a9e-bd74-e71797f951bb2022-04-27Exact identifier
unii: XF417D3PSL
Naloxone Hydrochloride Injection, USP, Auto-InjectorNALOXONE HYDROCHLORIDEKaleo, Inc.b5463553-b775-47a3-8d10-31e01ca1ec722022-03-11Warnings, Adverse reactionsExact identifier
unii: F850569PQR
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.22805f0d-ba58-41ea-b245-19980abcda222022-02-11Exact identifier
unii: 1Q73Q2JULR
unii: XF417D3PSL
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEInternational Medication Systems, Limitedd2f5bfa0-933e-46d0-8b1a-9f90e6aaba542021-12-13Warnings, Adverse reactionsExact identifier
unii: F850569PQR
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.d763511e-f1a7-4014-94b9-f7ad8f023ff42021-12-02Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.cf9f43a0-c750-4cf0-ac49-176ab2105aab2021-12-02Exact identifier
unii: XF417D3PSL
naloxone hydrochlorideNALOXONE HYDROCHLORIDEBaxter Healthcare Corporationd04ae2d7-01b9-405d-bb7a-bf2d876ce26a2021-07-02Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMylan Institutional LLCd96ebf2e-1051-4b5b-b1c6-2543dbbb2d042021-04-21Warnings, Adverse reactionsExact identifier
unii: F850569PQR
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEBaxter Healthcare Corporation3d8813be-6d22-46f1-ac25-0d8a817a521c2020-11-25Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMylan Institutional LLCf0932877-1f3b-4d5e-82d2-dd6c53db47302020-08-17Warnings, Adverse reactionsExact identifier
unii: F850569PQR

Reported adverse events (FAERS/openFDA)#

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