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 2 of 4 · 80 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BumetanideBUMETANIDEProficient Rx LPae7dd557-f7a1-4d5a-b80e-3ca3a6e4943b2026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197419
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDESun Pharmaceutical Industries, Inc.5c753aae-77b7-4add-8453-385a8f62d7db2026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197419
rxcui: 197417
rxcui: 197418
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEAvPAK87385a0a-e7e6-8b7f-e053-2991aa0aa21a2026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197419
rxcui: 197417
rxcui: 197418
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEMullan Pharmaceutical Inc.b7cd724b-817b-4b45-8133-1ebf505867e72026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEFirst Nation Group, LLC79b77945-74a7-4cb5-8aa0-33a7babdf6d92026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197419
rxcui: 197417
rxcui: 197418
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEA-S Medication Solutionsc8e243c0-805a-4d81-bec9-f5be6eb9f2bc2026-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197419
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDENovadoz Pharmaceuticals LLCcddd33fb-25b0-49ca-ab32-7c79a9b3a3842026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197419
rxcui: 197417
rxcui: 197418
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEA-S Medication Solutionsb338ae20-fc07-4ec5-9e68-be636f75ce1a2026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197419
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEA-S Medication Solutionsf4326e53-5217-48d4-a089-1184442049ac2026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197417
unii: 0Y2S3XUQ5H
bumetanideBUMETANIDEA-S Medication Solutions8b5a38cc-1e76-4821-b286-31bad3bd69132026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197419
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEExelan Pharmaceuticals, Inc.06745425-e7e7-4413-b9ff-22b121f0ea9a2026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197419
rxcui: 197417
rxcui: 197418
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDENCS HealthCare of KY, LLC dba Vangard Labsfa4e5faf-c91a-457b-bd2b-14a9add51ac82026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA213942
rxcui: 197419
rxcui: 197417
rxcui: 197418
unii: 0Y2S3XUQ5H
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
BumetanideBUMETANIDEA-S Medication Solutionse3d38c1d-9b35-478e-bc2f-3e82b09a15382026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197419
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEAdvagen Pharma Limited94078edd-b9c0-449e-baaf-a9afceccb4072026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA213942
ndc (product): 72888-020
rxcui: 197419
rxcui: 197417
rxcui: 197418
spl id: 47c8ef6a-8934-2514-e063-6294a90abae6
spl set id: 94078edd-b9c0-449e-baaf-a9afceccb407
unii: 0Y2S3XUQ5H
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
BumetanideBUMETANIDEEdenbridge Pharmaceuticals LLC.32c4372e-54ea-4fc8-b9f8-827fa4c8edd32025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197419
rxcui: 197417
rxcui: 197418
unii: 0Y2S3XUQ5H
BUMETANIDEBUMETANIDELupin Pharmaceuticals, Inc.2c71a17e-ed76-4545-b23e-9f4997b13c2f2025-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEBryant Ranch Prepack12b9489a-b16b-4504-a660-e66fd52610692025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197419
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEA-S Medication Solutions14e92f79-2c7b-4ab9-844f-e7bd1964f8b22025-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA213942
rxcui: 197417
unii: 0Y2S3XUQ5H

Reported adverse events (FAERS/openFDA)#

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