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 12 of 17 · 334 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEAsclemed USA, Inc.7acf3bde-f858-4fbc-8a11-6741a3d27b8e2024-10-29WarningsExact identifier
unii: F850569PQR
Buprenorphine Sublingual C-IIIBUPRENORPHINE SUBLINGUAL C-IIIDirect_Rx22412030-a641-28d8-e063-6294a90a2fef2024-10-16Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine Sublingual C-IIIBUPRENORPHINE SUBLINGUAL C-IIIDirect_Rx248524c6-4c8b-a450-e063-6394a90a81ef2024-10-15Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
teruflex blood bag system with diversion blood sampling arm 70 ml cpda-1ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation86b3a329-c83f-4977-92f5-0e9dfe1872d72024-10-10WarningsExact identifier
unii: XF417D3PSL
Bio Co-Enzyme PhaseCARDUUS MARIANUS, 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.afad858e-064f-454d-be78-da1501ffe8532024-10-04WarningsExact identifier
unii: XF417D3PSL
naloxone hydrochlorideNALOXONE HYDROCHLORIDEBaxter Healthcare Corporation48137634-91d7-41e3-b54b-e4321d69668a2024-10-04Warnings, Adverse reactionsExact identifier
unii: F850569PQR
TERUFLEX BLOOD with Diversion Blood Sampling Arm 70 mL CPDA-1ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation39f2e11c-5a31-469f-b725-d096c16744212024-10-03WarningsExact identifier
unii: XF417D3PSL
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEBryant Ranch Prepacked549649-dcbd-41f7-a774-876906751c5a2024-10-03WarningsExact identifier
unii: F850569PQR
TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of BloodANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation02015040-9b71-4dbe-8f8d-e0d0951e8f932024-09-19WarningsExact identifier
unii: XF417D3PSL
Buprenorphine SublingualBUPRENORPHINE SUBLINGUALDirect_rx2204e135-6a0c-68a2-e063-6394a90ac0192024-09-13Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
ammonia inhalantsINHALANTEpic Medical Supply Corp20e849e5-8517-b9fd-e063-6394a90a0d232024-09-03WarningsExact identifier
unii: 5138Q19F1X
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEAmerican Health Packagingb05b0087-c0ef-40be-9bf3-3933f6cd34922024-08-20Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Quality Choice Effervescent Antacid and Pain Relief - Extra StrengthASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association1f926637-a61c-8eb7-e063-6394a90a65022024-08-13WarningsExact identifier
unii: XF417D3PSL
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAmerican Health Packaging58fa9952-c8ab-4ebb-a073-15cc45f4832a2024-07-16Adverse reactionsExact identifier
unii: 1Q73Q2JULR
unii: XF417D3PSL
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEEugia US LLCc7fa8d4f-28a7-4ef5-aef8-cbd4328ce5992024-07-06Warnings, Adverse reactionsExact identifier
unii: F850569PQR
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEEugia US LLC2725b9c0-5b1e-498b-9ec5-ee76a62e656a2024-07-06Warnings, Adverse reactionsExact identifier
unii: F850569PQR
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC1be2e38b-55ca-abea-e063-6394a90ac5482024-06-27WarningsExact identifier
unii: F850569PQR
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell RX, LLC525136c9-7758-437b-b57b-94b9057868252024-05-31Adverse reactionsExact identifier
unii: 1Q73Q2JULR
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst19b0603b-241f-f439-e063-6294a90ae85f2024-05-30WarningsExact identifier
unii: F850569PQR
REFL HSADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREAS SUIS, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI)Deseret Biologicals, Inc.83249aee-f58b-442d-9187-6de0cf070e4d2024-04-29WarningsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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