FDA.reportPublic FDA data

NDC 43598-581-01 - 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
43598-581
Requested NDC
43598-581-01
Package NDCs from labels
43598-581-01, 43598-581-30
Manufacturer
Dr.Reddys Laboratories Inc | LTS Lohmann Therapy Systems Corp. | Pharmaron Manufacturing services (UK) LTD
Effective date
2026-01-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Buprenorphine and NaloxoneDr.Reddys Laboratories Inc | LTS Lohmann Therapy Systems Corp. | Pharmaron Manufacturing services (UK) LTD2026-01-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-581-01Buprenorphine and Naloxone1 in 1 POUCHFILM, SOLUBLE111
43598-581-30Buprenorphine and Naloxone30 in 1 CARTONFILM, SOLUBLE3011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-581BUPRENORPHINE AND NALOXONE FILM, SOLUBLE [DR.REDDYS LABORATORIES INC]9Current NDC, Legacy NDC, 2 package rows20240125_72dc1ec0-7c59-a587-4ffd-c40ef79e6fb2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-581-01EA - Each43598-58160f82d87-d0ad-4d84-930e-4910e6b1352d12019-03-12
43598-581-30EA - Each43598-5814964c819-812a-46b9-a7d0-9e09fb6a87d912019-03-12

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 · 244 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
unii: 56W8MW3EN1
Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEBryant Ranch Prepackb9b5b1d5-482e-42ad-aabd-869e9ade51262026-05-14Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
buprenorphine hydrochloride and naloxone hydrochloride dihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEBryant Ranch Prepacka0f8c28c-ed9a-4a26-91a3-b996c117ac2c2026-05-14Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
buprenorphine hydrochloride and naloxone hydrochloride dihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEBryant Ranch Prepackd25b1a73-9794-4e86-82eb-dee3f159a2142026-05-13Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Sodium PhosphatesSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC, ANHYDROUSHospira, Inc.6f044d16-295e-43ff-72a3-b045c387bc5c2026-05-11Warnings, Adverse reactionsExact identifier
unii: 22ADO53M6F
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
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
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
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONERedpharm Drug5005a6c8-9a3b-a99a-e063-6294a90aac132026-04-22Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEBryant Ranch Prepack63aaa6cc-8574-4990-8239-6fdeffce92c82026-04-16Warnings, Adverse reactionsExact identifier
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
unii: 56W8MW3EN1
CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.e95fff66-4ec0-4001-a727-33e66a5ec7d52026-04-15Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEAveva Drug Delivery Systems Inc.cb112448-49a1-4209-bcdb-7cfae6501f512026-04-07Warnings, Adverse reactionsExact identifier
rxcui: 1307056
rxcui: 1307061
unii: 56W8MW3EN1
Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium PhosphateDIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATERising Pharma Holdings, Inc.b01eac95-dbe3-4b21-a922-187e0fc8ad232026-04-07Adverse reactionsExact identifier
unii: 22ADO53M6F
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepackcd0a90c6-32cc-4114-8573-86ac85503bdf2026-04-03Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HCl and Naloxone HClBUPRENORPHINE AND NALOXONEBryant Ranch Prepack2aaad1a7-a0fd-4dd5-bb53-03afad8f10b92026-04-03Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1

Reported adverse events (FAERS/openFDA)#

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