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 8 of 8 · 142 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
application number: ANDA074700
rxcui: 197418
unii: 0Y2S3XUQ5H

Reported adverse events (FAERS/openFDA)#

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