FDA.reportPublic FDA data

NDC 69238-1490-01 - 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
69238-1490
Requested NDC
69238-1490-01
Package NDCs from labels
69238-1490-1, 69238-1490-5, 69238-1490-01
Manufacturer
Major Pharmaceuticals
Effective date
2026-08-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bumetanide - Major PharmaceuticalsMajor Pharmaceuticals2026-08-05HUMAN PRESCRIPTION DRUG LABEL
Bumetanide - AvPAKAvPAK2026-03-11HUMAN 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
Bumetanide - A-S Medication SolutionsA-S Medication Solutions2023-12-09HUMAN PRESCRIPTION DRUG LABEL
Bumetanide - Bryant Ranch PrepackBryant Ranch Prepack2021-12-28HUMAN PRESCRIPTION DRUG LABEL
Bumetanide Tablets, USP (0.5 mg, 1 mg and 2 mg) Rx OnlyNuCare Pharmaceuticals,Inc.2021-02-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1490-1Bumetanide100 in 1 BOTTLETABLET1009
69238-1490-5Bumetanide500 in 1 BOTTLETABLET5009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1490BUMETANIDE 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
69238-1490-1EA - Each69238-1490840c301e-8246-4f28-be9e-1dc6e63ee4a112017-12-14
69238-1490-5EA - Each69238-149075fe4004-b129-4417-865a-b07ad2695a8f12017-12-14

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 4 of 5 · 83 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BumetanideBUMETANIDEBryant Ranch Prepack0fb6d547-9966-4352-8974-d02ea58e64452024-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197418
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEProficient Rx LP6e3d3ea1-830f-4fc6-9c56-b2ec71875dc62024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197418
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDERising Pharma Holdings, Inc627c9732-eed1-4435-8d79-2e19ab974fd92024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197419
rxcui: 197417
rxcui: 197418
unii: 0Y2S3XUQ5H
1a5392ed-8c3e-fc80-e063-6394a90a536868193e08-c01d-6013-e053-2991aa0a71d92024-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: 68193e08-c01d-6013-e053-2991aa0a71d9
bumetanideBUMETANIDEBryant Ranch Prepacka60bfe5f-d0d6-4d15-a3de-32dc68e41af32024-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197418
unii: 0Y2S3XUQ5H
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
BumetanideBUMETANIDEBryant Ranch Prepackf6f12a41-ae6d-4ce6-9bb1-e32679af665f2024-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197419
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEAmneal Pharmaceuticals NY LLC9188ab17-8539-48a5-905f-ad35ab5a0b932023-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA209724
ndc (package): 69238-1490-1
ndc (package): 69238-1491-5
ndc (package): 69238-1491-1
ndc (package): 69238-1489-5
ndc (package): 69238-1490-5
ndc (package): 69238-1489-1
ndc (product): 69238-1491
ndc (product): 69238-1490
ndc (product): 69238-1489
ndc11 (package): 69238149001
rxcui: 197419
rxcui: 197417
rxcui: 197418
spl id: d1961e90-3fcc-4b72-b207-6c9de6d66557
spl set id: 9188ab17-8539-48a5-905f-ad35ab5a0b93
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEA-S Medication Solutionsd85bbced-8a9e-414d-bc88-dd0b68c118df2023-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA209724
ndc (package): 50090-5666-2
ndc (package): 50090-5666-0
ndc (product): 50090-5666
rxcui: 197418
spl id: b626e5ea-7a48-4525-b9a3-d7c0739639dd
spl set id: d85bbced-8a9e-414d-bc88-dd0b68c118df
unii: 0Y2S3XUQ5H
bumetanideBUMETANIDEZydus Pharmaceuticals (USA) Inc.525138cd-832a-41d0-84b0-83921b12bd2a2023-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197419
rxcui: 197417
rxcui: 197418
unii: 0Y2S3XUQ5H
bumetanideBUMETANIDEZydus Lifesciences Limited82eb62ca-c32b-4ff8-9f71-43219b2404802023-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197419
rxcui: 197417
rxcui: 197418
unii: 0Y2S3XUQ5H
bumetanideBUMETANIDEA-S Medication Solutionscf29e436-b630-4b03-bb9b-9267ae77dc002023-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197418
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDESandoz Inc05cb961d-ac33-4bcf-b04e-411e496c43c12023-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197419
rxcui: 197417
rxcui: 197418
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDECivica, Inc.308c690f-c2bd-4c32-8728-42ec95425f772023-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
191a28da-3e70-4d87-8416-d32cf07d857833566b78-b939-4cd1-a3ef-1a297f8d2b842023-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: 33566b78-b939-4cd1-a3ef-1a297f8d2b84
BumetanideBUMETANIDEA-S Medication Solutions7f9dccf8-37ff-454b-9d55-7f1d631c84832023-01-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197418
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEGLENMARK PHARMACEUTICALS INC., USA680563fe-5d3a-49bc-86a5-740bda2acebe2023-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEA-S Medication Solutionsf6ff0d37-c67d-4b9f-8b62-5deda9783c282023-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197417
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEA-S Medication Solutions8bed63fb-91ec-4132-ac0a-16c4c6f58d952023-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197419
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEFresenius Kabi USA, LLCa007f3aa-3977-4be3-a9a2-db3d458bca582022-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H

Reported adverse events (FAERS/openFDA)#

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