FDA.reportPublic FDA data

NDC 69238-1489-01 - 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
69238-1489
Requested NDC
69238-1489-01
Package NDCs from labels
69238-1489-1, 69238-1489-5, 69238-1489-01
Manufacturer
AvPAK
Effective date
2026-03-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bumetanide - AvPAKAvPAK2026-03-11HUMAN PRESCRIPTION DRUG LABEL
Bumetanide - A-S Medication SolutionsA-S Medication Solutions2026-02-02HUMAN PRESCRIPTION DRUG LABEL
Bumetanide - NCS HealthCare of KY, LLC dba Vangard LabsNCS HealthCare of KY, LLC dba Vangard Labs2024-10-18HUMAN PRESCRIPTION DRUG LABEL
Bumetanide Tablets, USP (0.5 mg, 1 mg and 2 mg) Rx OnlyAmneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals Private Limited2023-12-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1489-1Bumetanide100 in 1 BOTTLETABLET1009
69238-1489-5Bumetanide500 in 1 BOTTLETABLET5009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1489BUMETANIDE TABLET [AMNEAL PHARMACEUTICALS NY LLC]9Current NDC, Legacy NDC, 2 package rows20231230_9188ab17-8539-48a5-905f-ad35ab5a0b93.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1489-1EA - Each69238-1489c81ed181-9f97-472c-bc60-8fa58b6d383912017-12-14

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 · 79 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
application number: ANDA209724
ndc (package): 50268-130-15
ndc (package): 50268-130-11
ndc (package): 50268-131-15
ndc (package): 50268-132-11
ndc (package): 50268-132-15
ndc (package): 50268-131-11
ndc (product): 50268-132
ndc (product): 50268-130
ndc (product): 50268-131
rxcui: 197419
rxcui: 197417
rxcui: 197418
spl id: 4cc52e19-c90a-933d-e063-6294a90a917c
spl set id: 87385a0a-e7e6-8b7f-e053-2991aa0aa21a
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
application number: ANDA209724
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
application number: ANDA209724
ndc (package): 50090-5664-0
ndc (product): 50090-5664
rxcui: 197417
spl id: 1b3acb4a-bcb0-42d5-8600-6bf02fcc06c0
spl set id: f4326e53-5217-48d4-a089-1184442049ac
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
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
rxcui: 197419
rxcui: 197417
rxcui: 197418
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
rxcui: 197417
unii: 0Y2S3XUQ5H

Reported adverse events (FAERS/openFDA)#

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