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 13 of 13 · 244 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.448a1dc5-7a98-4b2f-82af-4b92de05cfc32019-11-18Exact identifier
unii: XF417D3PSL
Ammonia InhalantsAMMONIA INHALANTSJames Alexander Corporationb741afa6-e56c-4fbb-ada0-80b80aef72a72019-01-31WarningsExact identifier
unii: 5138Q19F1X
First Aid Only Ammonia InhalantsAMMONIA INHALANTSAcme United Corporation6595a2a5-f2d7-85cf-e053-2991aa0a9b522018-02-19WarningsExact identifier
unii: 5138Q19F1X
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.051f7347-5a76-4664-8fe2-e61b3dfcb0e42014-08-27Exact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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