FDA.reportPublic FDA data

NDC 55154-4345-00 - Bumetanide

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
55154-4345
Requested NDC
55154-4345-00
Package NDCs from labels
55154-4345-0, 55154-4345-00
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-05-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bumetanide - Cardinal Health 107, LLCCardinal Health 107, LLC2026-05-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-4345-0Bumetanide10 in 1 BAGTABLET108
55154-4345-0Bumetanide1 in 1 BLISTER PACKTABLET18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4345BUMETANIDE TABLET [CARDINAL HEALTH 107, LLC]5Current NDC, Legacy NDC, 2 package rows20240815_0a5577f5-d2fe-4b0d-8245-78ee77df30fd.zip

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 1 of 5 · 81 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BumetanideBUMETANIDEREMEDYREPACK INC.de008936-e8a3-4e65-bb6a-d925b68a5f502026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197418
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEREMEDYREPACK INC.0fb78afc-d8bc-4ae8-8c0a-6d9c6f7a22c52026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197419
unii: 0Y2S3XUQ5H
EnbumystBUMETANIDECorstasis USA LLCd6f752c5-d2bd-4f77-9611-ca2110066d1f2026-08-27Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDENorthStar Rx LLC551918e1-96c4-453a-870c-61b2828822062026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197419
rxcui: 197417
rxcui: 197418
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEMajor Pharmaceuticalsa29cf117-00d0-4948-b646-013c8791ea392026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA209724
rxcui: 197418
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDESagent Pharmaceuticalsc38a404d-a919-4a2c-9fbb-d0655dee95162026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDECivica, Inc.4a9229c8-89ba-423e-8e36-f56bc329ed382026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEHikma Pharmaceuticals USA Inc.681b5e9d-e2c7-4f29-aaad-e06d4a528c112026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEAnthea Pharma Private Limited9058fc52-f3f6-4d7f-b2a0-b1e2c714b1332026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDECardinal Health 107, LLCe7c3c63e-3aea-4b33-b165-7c74493596742026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDESandoz Inc8914d8bf-61b7-4cd2-a8ef-7e1c5df378282026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197419
rxcui: 197417
rxcui: 197418
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEA-S Medication Solutionsa4dd156d-0f17-43d9-bf78-2d358c50681b2026-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197418
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEBryant Ranch Prepack43ab2dd6-39ba-4a53-aa84-d7975038ef432026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEBryant Ranch Prepack37179b2d-6589-40d8-8121-7561a6791d382026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDECardinal Health 107, LLC0a5577f5-d2fe-4b0d-8245-78ee77df30fd2026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA209724
ndc (package): 55154-4345-0
ndc (product): 55154-4345
ndc11 (package): 55154434500
rxcui: 197418
spl id: b92d813a-5082-4af2-a8db-61bddce0fc4b
spl set id: 0a5577f5-d2fe-4b0d-8245-78ee77df30fd
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDECardinal Health 107, LLC9bd4fcd3-3020-41f2-b112-023b5db4487d2026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA209724
rxcui: 197418
unii: 0Y2S3XUQ5H
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
BumetanideBUMETANIDECardinal Health 107, LLC68f18d36-ffc2-4481-9286-914cfcf573a02026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEProficient Rx LP51d5f639-5d25-4ada-8bbe-ada2386173bf2026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197418
unii: 0Y2S3XUQ5H

Reported adverse events (FAERS/openFDA)#

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