FDA.reportPublic FDA data

NDC 69238-1491-01 - 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
69238-1491
Requested NDC
69238-1491-01
Package NDCs from labels
69238-1491-1, 69238-1491-5, 69238-1491-01
Manufacturer
AvPAK
Effective date
2026-03-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bumetanide - AvPAKAvPAK2026-03-11HUMAN PRESCRIPTION DRUG LABEL
Bumetanide - A-S Medication SolutionsA-S Medication Solutions2026-02-11HUMAN 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 Tablets, USP (0.5 mg, 1 mg and 2 mg) Rx OnlyREMEDYREPACK INC.2022-01-31HUMAN 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
69238-1491-1Bumetanide100 in 1 BOTTLETABLET1009
69238-1491-5Bumetanide500 in 1 BOTTLETABLET5009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1491BUMETANIDE 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
69238-1491-1EA - Each69238-1491e1ebf74d-b711-4811-98ae-344f3fcfb00212017-12-14
69238-1491-5EA - Each69238-14912861f5e8-6868-4bc5-b191-7f54611f3f3212017-12-14

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 5 of 5 · 81 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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.