FDA.reportPublic FDA data

NDC 72162-2197-01 - 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
72162-2197
Requested NDC
72162-2197-01
Package NDCs from labels
72162-2197-1, 72162-2197-5, 72162-2197-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-01-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bumetanide - Bryant Ranch PrepackBryant Ranch Prepack2024-01-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2197-1Bumetanide100 in 1 BOTTLETABLET100101
72162-2197-5Bumetanide500 in 1 BOTTLETABLET500101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2197BUMETANIDE TABLET [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20240127_f6f12a41-ae6d-4ce6-9bb1-e32679af665f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2197-1EA - Each72162-21971cfafe6a-7bbb-45d6-b6d6-65d6f0e1d26212024-03-12
72162-2197-5EA - Each72162-219722fd5621-3f37-4a21-8fb5-e243926d3cad12024-01-04

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 7 of 8 · 142 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BumetanideBUMETANIDEProficient Rx LP6e3d3ea1-830f-4fc6-9c56-b2ec71875dc62024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074700
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
CalamineFERRIC OXIDE REDNuCare Pharmaceuticals,Inc.66e98554-e158-a519-e053-2a91aa0a67832024-06-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
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
application number: ANDA074700
ndc (package): 72162-2197-5
ndc (package): 72162-2197-1
ndc (product): 72162-2197
ndc11 (package): 72162219701
rxcui: 197419
spl id: 16d018df-4755-498d-8fcf-b6b06933588e
spl set id: f6f12a41-ae6d-4ce6-9bb1-e32679af665f
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEAmneal Pharmaceuticals NY LLC9188ab17-8539-48a5-905f-ad35ab5a0b932023-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197419
rxcui: 197417
rxcui: 197418
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEA-S Medication Solutionsd85bbced-8a9e-414d-bc88-dd0b68c118df2023-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197418
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
application number: ANDA074700
ndc (product): 0185-0130
rxcui: 197419
rxcui: 197417
rxcui: 197418
spl id: c6f31ac9-10d1-4d92-882e-836de10e1ce6
spl set id: 05cb961d-ac33-4bcf-b04e-411e496c43c1
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDECivica, Inc.308c690f-c2bd-4c32-8728-42ec95425f772023-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0Y2S3XUQ5H
Ferrum OxydatumFERRUM OXYDATUMHahnemann Laboratories, INC.f8b52d3f-3fe2-a850-e053-6394a90a5d9f2023-04-06Exact identifier
unii: 1K09F3G675
BumetanideBUMETANIDEA-S Medication Solutions7f9dccf8-37ff-454b-9d55-7f1d631c84832023-01-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074700
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
application number: ANDA074700
rxcui: 197417
unii: 0Y2S3XUQ5H
BumetanideBUMETANIDEA-S Medication Solutions8bed63fb-91ec-4132-ac0a-16c4c6f58d952023-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074700
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

Reported adverse events (FAERS/openFDA)#

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