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 4 of 13 · 244 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHOSPHA 250 NEUTRALDIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATERising Pharma Holdings, Inc.9432adfc-6add-4ab4-ae93-2e2daf348be22026-03-25Adverse reactionsExact identifier
unii: 22ADO53M6F
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEINGENUS PHARMACEUTICALS, LLC4951ec29-609b-4836-b0e4-0d9c1d6ae6fe2026-03-23Warnings, Adverse reactionsExact identifier
rxcui: 1307056
rxcui: 1307061
unii: 56W8MW3EN1
Buprenorphine HClBUPRENORPHINE HCLREMEDYREPACK INC.69a647c0-bc09-4ee2-aeb3-ef286caf25e52026-03-23Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
buprenorphine hydrochloride and naloxone hydrochloride dihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEClinical Solutions Wholesale, LLC99a5b62f-bc08-44f4-abb8-300520d2162a2026-03-06Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEClinical Solutions Wholesale, LLC8f2b94dc-f42f-45d5-8274-9e748ec20ef02026-03-05Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
buprenorphine hydrochloride and naloxone hydrochloride dihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEMajor Pharmaceuticalsc5fbec69-e7de-44a8-b9fa-0378ae61a9fe2026-03-03Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
buprenorphine hydrochlorideBUPRENORPHINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma442831cf-9636-433a-9a12-e9a8cd31f72a2026-02-28Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharmad5b011ef-f1be-47f2-8f8b-07553f36193c2026-02-28Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
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.23de6b8e-7622-4ba6-89f7-37bd151687e22026-02-26WarningsExact identifier
unii: XF417D3PSL
Leader Extra Strength Effervescent Antacid and Pain RelieverASPIRIN, CITRIC ACID, SODIUM BICARBONATECardinal Healthc5d7bf5f-3e59-52f2-e053-2a95a90a4a002026-02-25WarningsExact identifier
unii: XF417D3PSL
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONERedpharm Drug300ae3d0-464c-d0be-e063-6294a90a7f9d2026-02-21Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEUnit Dose Solutions, Inc.4b301ad7-ac0e-f849-e063-6394a90a27d52026-02-19Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
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.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: XF417D3PSL
BuprenorphineBUPRENORPHINESun Pharmaceutical Industries, Inc.9fd1f18f-0b0f-4059-b603-19ecbf0ed63a2026-02-11Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONESun Pharmaceutical Industries, Inc.91b68606-05de-4586-ae31-07e8cc9160cf2026-02-10Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
BUPRENORPHINEBUPRENORPHINEA-S Medication Solutionsbfb02ea5-22f2-432e-afc8-f1dbe2ea06142026-02-06Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEActavis Pharma, Inc.6cccf229-9611-4b6f-8f1b-acc8ff1ed3f82026-02-06Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HCl and Naloxone HClBUPRENORPHINE AND NALOXONEAmneal Pharmaceuticals LLC17b63f10-c9df-44be-80fa-6f1c305583b82026-02-02Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Snap Labs Ammonia InhalantsAMMONIA INHALANTBrined LLC d/b/a Snap Labs4926daad-a250-a40a-e063-6394a90a95962026-01-30WarningsExact identifier
unii: 5138Q19F1X
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONECamber Pharmaceuticals, Inc.221195e4-de08-414c-af08-a611a74789de2026-01-30Warnings, Adverse reactionsExact identifier
rxcui: 1307056
rxcui: 1307061
unii: 56W8MW3EN1

Reported adverse events (FAERS/openFDA)#

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