FDA.reportPublic FDA data

NDC 70518-4385-00 - 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
70518-4385
Requested NDC
70518-4385-00
Package NDCs from labels
70518-4385-0, 70518-4385-00
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bumetanide - REMEDYREPACK INC.REMEDYREPACK INC.2026-09-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4385-0Bumetanide90 in 1 BOTTLE, PLASTICTABLET902

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
application number: ANDA213942
ndc (package): 70518-4385-0
ndc (product): 70518-4385
ndc11 (package): 70518438500
rxcui: 197418
spl id: 5b0fffc7-1331-719d-e063-6294a90ac9f4
spl set id: de008936-e8a3-4e65-bb6a-d925b68a5f50
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
application number: ANDA213942
rxcui: 197419
rxcui: 197417
rxcui: 197418
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEMajor Pharmaceuticalsa29cf117-00d0-4948-b646-013c8791ea392026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
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
rxcui: 197418
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDECardinal Health 107, LLC9bd4fcd3-3020-41f2-b112-023b5db4487d2026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
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.