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 8 of 17 · 334 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.5be36a7f-7d1f-468d-9c29-92c8cd3ef1bc2025-12-04WarningsExact identifier
unii: XF417D3PSL
BuprenorphineBUPRENORPHINERedpharm Drug3dd00186-1f1f-642a-e063-6294a90a6d202025-12-02Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.ab19b011-0a51-4f04-9881-d9fc7cae95ae2025-11-25Exact identifier
unii: 1Q73Q2JULR
unii: XF417D3PSL
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEStrategic Sourcing Services LLC577fbd57-7054-4536-86c1-d43bc99cc7b12025-11-19WarningsExact identifier
unii: F850569PQR
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATER J General Corporationdbb0d067-71f0-45e4-bc98-548cf4a90b3a2025-11-17WarningsExact identifier
unii: XF417D3PSL
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHenry Schein, Inc.ddeebc32-9aab-4a2f-8c87-74335d17d5ef2025-10-28Warnings, Adverse reactionsExact identifier
unii: F850569PQR
KINKANAMMONIA, CAMPHOR (NATURAL), MENTHOLKINKANDO CO., LTD .f2c0f3e1-792b-4798-bf6d-acd1bbefa2612025-10-21WarningsExact identifier
unii: 5138Q19F1X
Walgreens Antacid Pain Relief Extra StrengthASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalgreensb60df498-07db-500b-e053-2a95a90aff6a2025-10-17WarningsExact identifier
unii: XF417D3PSL
Equate Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalmart6271b34b-55a0-40a8-e053-2a91aa0acb222025-10-17Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Mitochondria PROARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.8c3e961d-bc33-40cd-a282-a4fe5aa3f0ad2025-10-06WarningsExact identifier
unii: XF417D3PSL
Kidnex IVGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, GERMANIUM SESQUIOXIDE, MERCURIUS VIVUS, NUX VOMICA, KIDNEY (SUIS), LYMPH NODE (SUIS), NAPHTHOCHINONUM, NATRUM OXALACETICUM, PHOSPHORUS, URINARY BLADDER (SUIS), ACONITICUM ACIDUM, CIS-Energique, Inc.121eb51a-befe-47ea-85c6-d77e8c7e58642025-10-06WarningsExact identifier
unii: XF417D3PSL
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEProPharma Distribution3f2bb95a-aeca-c0b7-e063-6394a90a627b2025-09-19Warnings, Adverse reactionsExact identifier
unii: F850569PQR
UpSniff Smelling SaltsSMELLING SALTSShenzhen Nanjun Technology Co., Ltd3e7e4c2c-08bc-37b7-e063-6394a90a6b212025-09-10WarningsExact identifier
unii: 5138Q19F1X
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.e6467385-6990-498c-8a0e-f4a40ef33cb72025-09-02Warnings, Adverse reactionsExact identifier
unii: F850569PQR
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEAMERISOURCE BERGENcce38c13-0d2f-49bb-94fa-6f2bbb4d59842025-08-31WarningsExact identifier
unii: F850569PQR
PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEPENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDELupin Pharmaceuticals,Inc.017ef042-40aa-44c9-baa8-037f063568452025-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: F850569PQR
KLOXXADONALOXONE HCLHikma Specialty USA Inc.ebf0f833-c1c0-487c-8f29-01fa8c61b6cb2025-08-25Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Ammonia InhalantsAMMONIA INHALANTSDynarex Corporation91e27f1c-0f74-413e-97ff-2fc013f22ca82025-08-11WarningsExact identifier
unii: 5138Q19F1X
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst3ba53405-5e72-c035-e063-6294a90ac0b12025-08-05Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEFresenius Kabi USA, LLC201fdedf-1736-4e52-9d7d-de14292547fd2025-07-31Warnings, Adverse reactionsExact identifier
unii: F850569PQR

Reported adverse events (FAERS/openFDA)#

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