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 8 of 13 · 244 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bio Co Enzyme PhaseACONITICUM ACIDUM, CIS-, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ADRENALINUM, , ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, ASCORBICUM ACIDUM, BARIUM OXALSUCCINICUM, BETA VULGARIS, CERIUM OXALICUM, CITRICUM ACIDUM, CYSTEINUM, FUMARICUM ACIDUM, HEPAR SULPHURIS CALCAREUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM PHOSPHORICUM, NADIDUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PANTOTHENIC ACID, PROTEUS (MORGANI), PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM,Deseret Biologicals, Inc.6edee6eb-0ec9-4d2a-9dc9-dc2a6503a6db2025-04-08WarningsExact identifier
unii: XF417D3PSL
Buprenorphine HClBUPRENORPHINE HCLBryant Ranch Prepackd5a8c41e-413e-4d48-9739-d158e5681dd02025-03-28Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HydrochlorideBUPRENORPHINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.adc1167e-910e-4d7b-abdc-751d3df0c3dc2025-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
BuprenorphineBUPRENORPHINEClinical Solutions Wholesale, LLC9d976ee7-9509-49da-89fd-48d7e712697b2025-02-17Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HydrochlorideBUPRENORPHINE HYDROCHLORIDESomerset Therapeutics, LLC74e40c51-853b-4e7f-b3cb-a27af29e1cbf2025-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
BuprenorphineBUPRENORPHINEClinical Solutions Wholesale, LLC023c7816-21b1-4f85-be36-9e32d5935c192025-02-03Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAvPAKfe070e2e-3e72-fb84-e053-6294a90afd882025-01-09Adverse reactionsExact identifier
unii: XF417D3PSL
BuprenorphineBUPRENORPHINEAmerican Health Packaging8d38f7aa-da0b-40ad-b0d1-4284c71042ed2024-12-30Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Equaline Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnited Natural Foods, Inc. dba UNFI739237a5-cc62-8ad6-e053-2991aa0a91f82024-12-17WarningsExact identifier
unii: XF417D3PSL
Alka-Seltzer Heartburn and PainANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.2928e140-c868-5bf5-e063-6394a90ab0242024-12-13WarningsExact identifier
unii: XF417D3PSL
Rite Aid Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATERite Aidb4797380-9cef-d640-e053-2a95a90a06652024-12-11WarningsExact identifier
unii: XF417D3PSL
Top Value Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICAROBONATETower Laboratories Ltd44babed8-cf38-1c12-e054-00144ff8d46c2024-12-11Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Best Choice Effervescent Antacid Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEValu Merchandisers Companyb5e2300a-b77b-53cc-e053-2a95a90a7a6e2024-12-11WarningsExact identifier
unii: XF417D3PSL
CVS Health Extra Strength Antacid and Pain RelieverASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATECVS Pharmacyafe9e755-18ba-305f-e053-2995a90aa8d02024-11-14WarningsExact identifier
unii: XF417D3PSL
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEPharmaceutical Associates, Inc.63201a61-6ac5-41ae-8b2d-ff0d3a8ddfd52024-11-13Adverse reactionsExact identifier
unii: XF417D3PSL
Walgreens Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalgreens667418fc-a3ab-cbc7-e053-2a91aa0a20232024-11-13WarningsExact identifier
unii: XF417D3PSL
Up and Up Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATETarget Corporationa72eef45-b985-638a-e053-2995a90aa20a2024-11-13WarningsExact identifier
unii: XF417D3PSL
Signature Care Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATESafeway, Inc6e120024-475a-73af-e053-2a91aa0a42a62024-11-13Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Kroger Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEKroger Company6d858b0e-a3c8-2686-e053-2991aa0acc062024-11-13WarningsExact identifier
unii: XF417D3PSL
TopCare Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATETopco Associates LLC639f9d57-f26a-708a-e053-2a91aa0a69622024-11-13Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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