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 5 of 8 · 142 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BumetanideBUMETANIDEBryant Ranch Prepack12b9489a-b16b-4504-a660-e66fd52610692025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074700
rxcui: 197419
unii: 0Y2S3XUQ5H
Calamine Plus Pramoxine HClCALAMINE PLUS NO TOUCH SPRAYPremier Brands of America Inc.36481d67-2346-470b-e063-6294a90aae992025-11-03WarningsExact identifier
unii: 1K09F3G675
BumetanideBUMETANIDEA-S Medication Solutions14e92f79-2c7b-4ab9-844f-e7bd1964f8b22025-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197417
unii: 0Y2S3XUQ5H
Calamine PlusCALAMINE PLUS PRAMOXINE HCLAmerisourceBergen Drug Corporationf161e151-4fab-2fbc-e053-2a95a90a54372025-10-30WarningsExact identifier
unii: 1K09F3G675
REMEDY Calazime Skin ProtectantCALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDEMedline Industries, LP1295cfcc-5b61-481b-964b-f53ffd0cb58e2025-10-30WarningsExact identifier
unii: 1K09F3G675
Calamine PlusCALAMINE PLUS PRAMOXINE HCLMeijer Distribution Inc.03c46823-0b1f-4101-e063-6294a90aaf942025-10-30WarningsExact identifier
unii: 1K09F3G675
Aveeno Anti-Itch ConcentratedZINC OXIDE, FERRIC OXIDE RED, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC07f4d4d0-9cee-46c3-bc71-2024abd31c9e2025-10-29WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYPremier Brands of America, Inc.d3452573-f91f-f157-e053-2a95a90a1ad82025-10-27WarningsExact identifier
unii: 1K09F3G675
BumetanideBUMETANIDEBryant Ranch Prepackb2dcdf9b-70b9-493f-99b4-fc7dcc31939a2025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074700
rxcui: 197418
unii: 0Y2S3XUQ5H
BumexBUMETANIDEValidus Pharmaceuticals LLC32dfbea3-eb2b-4070-8605-57ce3e6d5a2f2025-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197419
rxcui: 197417
rxcui: 197418
unii: 0Y2S3XUQ5H
PowderTITANIUM DIOXIDEOxygen Development LLC08b52f29-c1a0-c673-e063-6294a90a9a7a2025-09-05WarningsExact identifier
unii: 1K09F3G675
PowderTITANIUM DIOXIDEOxygen Development LLC08b8003f-40be-3380-e063-6294a90a4f6b2025-09-05WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYFSA Store Inc.3cd18f96-34f7-3f2c-e063-6294a90a3b7e2025-08-19WarningsExact identifier
unii: 1K09F3G675
BumetanideBUMETANIDEBryant Ranch Prepack6b5450f2-ae91-48b6-ad83-261bdfcf47ac2025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074700
rxcui: 197419
unii: 0Y2S3XUQ5H
bumetanideBUMETANIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.d4688d53-9baf-4cf0-b37f-47779bce78152025-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197419
rxcui: 197417
rxcui: 197418
unii: 0Y2S3XUQ5H
Ferrum rosatum GraphitesFERRUM ROSATUM GRAPHITESUriel Pharmacy Inc.1a4ca338-eada-4c0f-8bce-480244940c892025-06-27WarningsExact identifier
unii: 1K09F3G675
BumetanideBUMETANIDEBryant Ranch Prepacka7068f36-a863-4af0-9c82-e5394a6e7a542025-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074700
rxcui: 197418
unii: 0Y2S3XUQ5H
Steritalc 2gTALCNovatech SAc94e51d9-beef-4b06-e053-2a95a90a754a2025-06-25Warnings, Adverse reactionsExact identifier
unii: 7SEV7J4R1U
SENSITIVE POCKET SUNSENSITIVE POCKET SUNShantou Oushiya Biotechnology Co., Ltd36ac412f-e31f-6906-e063-6394a90a4a3d2025-06-14WarningsExact identifier
unii: 7SEV7J4R1U
AquavitAQUAVITUriel Pharmacy Inc.c1c0887a-c388-c737-e053-2a95a90a076c2025-06-06WarningsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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