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 3 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BuprenorphineBUPRENORPHINEActavis Pharma, Inc.03819118-86f6-4329-adaf-4599e7b71f462026-05-25Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATESelect Consumer Group3ca80d74-1e8b-49d9-e063-6394a90a43122026-05-24WarningsExact identifier
unii: XF417D3PSL
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEREMEDYREPACK INC.072b2c2e-a564-4bb4-8954-9349a79238072026-05-22Warnings, Adverse reactionsExact identifier
application number: ANDA205601
ndc (package): 70518-3389-0
ndc (product): 70518-3389
ndc11 (package): 70518338900
rxcui: 351267
spl id: 52687427-56f2-d377-e063-6394a90a8455
spl set id: 072b2c2e-a564-4bb4-8954-9349a7923807
unii: 5Q187997EE
unii: 56W8MW3EN1
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
unii: B22547B95K
Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEBryant Ranch Prepackb9b5b1d5-482e-42ad-aabd-869e9ade51262026-05-14Warnings, Adverse reactionsExact identifier
rxcui: 351267
unii: 5Q187997EE
unii: 56W8MW3EN1
buprenorphine hydrochloride and naloxone hydrochloride dihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEBryant Ranch Prepacka0f8c28c-ed9a-4a26-91a3-b996c117ac2c2026-05-14Warnings, Adverse reactionsExact identifier
rxcui: 351266
unii: 5Q187997EE
unii: 56W8MW3EN1
buprenorphine hydrochloride and naloxone hydrochloride dihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEBryant Ranch Prepackd25b1a73-9794-4e86-82eb-dee3f159a2142026-05-13Warnings, Adverse reactionsExact identifier
rxcui: 351266
unii: 5Q187997EE
unii: 56W8MW3EN1
Market Basket Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDemoulas Super Markets, Inc.e15439c7-0e3c-7752-e053-2995a90a1a402026-05-11WarningsExact identifier
unii: XF417D3PSL
Meijer Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEMeijer Distribution Inc7305972b-aa0f-4daa-e053-2991aa0adfd72026-05-11WarningsExact identifier
unii: XF417D3PSL
Free RadicalALFALFA, ASCORBYL PALMITATE, CYSTEINUM, DIMETHYL GLYCINE, FUCUS VESICULOSUS, HORDEUM VULGARE, L-METHIONINE, MANGANESE GLUCONATE, NASTURTIUM AQUATICUM, QUERCETIN, RAPHANUS SATIVUS, SODIUM SELENITE, TRITICUM AESTIVUM, UBIDECARENONUM, ALPHA-LIPOICUM ACIDUM, GABA (GAMMA AMINOBUTYRIC ACID), ORYZA SATIVA, VITAMIN E, ZINC PICOLINATE, COBALTUM METALLICUM, FERRUM METALLICUM, GLUTATHIONE, MAGNESIUM FLUORATUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUMDeseret Biologicals, Inc.36060680-f0d2-44c3-82fa-649e6e9d454d2026-05-06WarningsExact identifier
unii: H4N855PNZ1
BUPRENORPHINEBUPRENORPHINERhodes Pharmaceuticals LLCda90618a-5621-4b15-bc48-9dcc631418de2026-05-04Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONERhodes Pharmaceuticals LLC794724a6-0fba-bc8d-ecdb-9e3be8ea21912026-05-01Warnings, Adverse reactionsExact identifier
application number: ANDA205601
ndc (product): 42858-602
rxcui: 351266
rxcui: 351267
spl id: 57ae52a6-e7e9-442f-897f-e016078b4f11
spl set id: 794724a6-0fba-bc8d-ecdb-9e3be8ea2191
unii: 5Q187997EE
unii: 56W8MW3EN1
buprenorphine hydrochloride and naloxone hydrochloride dihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEGolden State Medical Supply, Inc.4f6e0056-b19d-0d0e-e063-6294a90a16e52026-04-24Warnings, Adverse reactionsExact identifier
rxcui: 351266
rxcui: 351267
unii: 5Q187997EE
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONERedpharm Drug5005a6c8-9a3b-a99a-e063-6294a90aac132026-04-22Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEBryant Ranch Prepack63aaa6cc-8574-4990-8239-6fdeffce92c82026-04-16Warnings, Adverse reactionsExact identifier
application number: ANDA205601
rxcui: 351267
unii: 5Q187997EE
unii: 56W8MW3EN1
Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEUnit Dose Solutions, Inc.4f979409-f9a2-d3a2-e063-6394a90accd02026-04-16Warnings, Adverse reactionsExact identifier
rxcui: 351266
rxcui: 351267
unii: 5Q187997EE
unii: 56W8MW3EN1
CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.e95fff66-4ec0-4001-a727-33e66a5ec7d52026-04-15Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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