FDA.reportPublic FDA data

NDC 50090-5666-00 - 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
50090-5666
Requested NDC
50090-5666-00
Package NDCs from labels
50090-5666-0, 50090-5666-2, 50090-5666-00
Manufacturer
A-S Medication Solutions
Effective date
2023-12-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bumetanide - A-S Medication SolutionsA-S Medication Solutions2023-12-09HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-5666-02023-02-07Bumetanide Tablets, USP (0.5 mg, 1 mg and 2 mg) Rx Only
50090-5666-22023-02-07Bumetanide Tablets, USP (0.5 mg, 1 mg and 2 mg) Rx Only
50090-5666-02023-01-30Bumetanide Tablets, USP (0.5 mg, 1 mg and 2 mg) Rx Only
50090-5666-22023-01-30Bumetanide Tablets, USP (0.5 mg, 1 mg and 2 mg) Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5666-0Bumetanide30 in 1 BOTTLETABLET306
50090-5666-2Bumetanide90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5666BUMETANIDE TABLET [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20231210_d85bbced-8a9e-414d-bc88-dd0b68c118df.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5666-2EA - Each50090-5666cfa270ed-66b9-4e71-b873-205c48c9a08312022-10-06

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 4 · 78 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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 (product): 69238-1490
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
ndc11 (package): 50090566600
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
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
BumetanideBUMETANIDENovadoz Pharmaceuticals LLC387edfd4-be85-41cd-8a6d-14e6a022b5a92022-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEGland Pharma Limited4d1ed6b2-c410-4f52-9b8a-aa256c37089e2022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEAphena Pharma Solutions - Tennessee, LLC7e47e7b1-d28a-4e12-882f-cf193b7f26972019-09-30Boxed 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.