FDA.reportPublic FDA data

NDC 70518-3389-00 - 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
70518-3389
Requested NDC
70518-3389-00
Package NDCs from labels
70518-3389-0, 70518-3389-00
Manufacturer
REMEDYREPACK INC.
Effective date
2026-05-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Buprenorphine and Naloxone - REMEDYREPACK INC.REMEDYREPACK INC.2026-05-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3389-0Buprenorphine and Naloxone30 in 1 BLISTER PACKTABLET308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3389BUPRENORPHINE AND NALOXONE TABLET [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 1 package rows20240709_072b2c2e-a564-4bb4-8954-9349a7923807.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3389-0EA - Each70518-3389efd1dd10-6bd2-4480-96ba-8aa2794568fb12026-01-08

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 5 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEActavis Pharma, Inc.6cccf229-9611-4b6f-8f1b-acc8ff1ed3f82026-02-06Warnings, Adverse reactionsExact identifier
rxcui: 351266
rxcui: 351267
unii: 5Q187997EE
unii: 56W8MW3EN1
Buprenorphine HCl and Naloxone HClBUPRENORPHINE AND NALOXONEAmneal Pharmaceuticals LLC17b63f10-c9df-44be-80fa-6f1c305583b82026-02-02Warnings, Adverse reactionsExact identifier
rxcui: 351266
rxcui: 351267
unii: 5Q187997EE
unii: 56W8MW3EN1
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: B22547B95K
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONECamber Pharmaceuticals, Inc.221195e4-de08-414c-af08-a611a74789de2026-01-30Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONELannett Company, Inc.14eaa94a-cc8a-4e1e-8cfb-5c976c96c6062026-01-28Warnings, Adverse reactionsExact identifier
rxcui: 351266
rxcui: 351267
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAtlantic Biologicals Corp.42d837ae-2578-46df-92d2-24774964aaad2026-01-28Adverse reactionsExact identifier
unii: XF417D3PSL
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONECamber Pharmaceuticals, Inc.5ab2d4e4-3c8c-413a-b147-23eafbde313a2026-01-28Warnings, Adverse reactionsExact identifier
rxcui: 351266
rxcui: 351267
unii: 5Q187997EE
unii: 56W8MW3EN1
Gethorey MIRACLE BALMHYALURONIC ACID 1% VITAMIN E 0.5% MIRACLE BALMJiangxi Yudexi Pharmaceutical Co., LTD496a7c75-cac5-f152-e063-6394a90a5ce42026-01-27WarningsExact identifier
unii: H4N855PNZ1
BuprenorphineBUPRENORPHINEHikma Pharmaceuticals USA Inc.1bf8b35a-b769-465c-a2f8-099868dfcd2f2026-01-24Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATERedpharm Drug44f2e26f-4586-5204-e063-6394a90a47d52026-01-23Warnings, Adverse reactionsExact identifier
rxcui: 351267
unii: 5Q187997EE
unii: 56W8MW3EN1
Buprenorphine HClBUPRENORPHINE HCLCamber Pharmaceuticals, Inc.b52cea0e-688f-4beb-bf7d-f228b81dbd232026-01-23Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEMylan Pharmaceuticals Inc.557d8d4d-8751-431c-b18e-9d5cf23fc5792026-01-15Warnings, Adverse reactionsExact identifier
unii: 5Q187997EE
unii: 56W8MW3EN1
WALGREENS UPSET STOMACH and NAUSEA RELIEFSODIUM CITRATE DIHYDRATEWALGREENS CO.2de7ff66-af75-4d9d-b493-29b37dadc5d82026-01-15WarningsExact identifier
unii: B22547B95K
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEDr.Reddys Laboratories Inc718756d7-0131-b173-6c45-5ee039b311b02026-01-12Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEDr.Reddys Laboratories Inc72dc1ec0-7c59-a587-4ffd-c40ef79e6fb22026-01-12Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
BuprenorphineBUPRENORPHINEAvPAK1408cd8f-a0b5-6be7-e063-6394a90a0b412026-01-08Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HCl and Naloxone HClBUPRENORPHINE AND NALOXONEAvPAKb955054b-b37d-4079-4fed-5939b763ecb42026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 351266
rxcui: 351267
unii: 5Q187997EE
unii: 56W8MW3EN1
Cell Energy Performance Drops 2048CELL ENERGY PERFORMANCE DROPSProfessional Complementary Health Formulas8701ea61-5d5f-466b-8d2c-f808e7b4d8fe2026-01-08WarningsExact identifier
unii: XF417D3PSL
Metab 6012METABProfessional Complementary Health Formulasf3576d6f-c9ab-4370-8a32-b6c4bf6ba4fd2026-01-08WarningsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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