FDA.reportPublic FDA data

Enbumyst (Bumetanide Nasal Spray)

Manufacturer
Renaissance Lakewood LLC
Effective date
2025-11-20
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
monthly-update
Hydrated at
2026-06-03 17:44:30

Label at a glance#

ProductEnbumyst
Active ingredientBUMETANIDE
Label structure2 sections

Label contents#

Full prescribing information#

instructions for use

INSTRUCTIONS FOR USE SECTION

Instructions for Use - EnbumystInstructions for Use - Enbumyst

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Enbumyst Carton LabelEnbumyst Carton Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1d3f2f0a-cce7-32fe-77bf-6ee61839e736Product name920260113
601d9750-f415-d9d9-619c-0a87b4d3f237Product name320250331
1d3f2f0a-cce7-32fe-77bf-6ee61839e736Product name220171211

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49396-005049396-0050-6, 49396-0050-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUMETANIDE0Y2S3XUQ5HACTIB

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
48734676-fadd-ee0b-e063-6294a90a5d684409c4a5-2090-7cb3-e063-6394a90a08722026-01-15Exact identifier
spl set id: 4409c4a5-2090-7cb3-e063-6394a90a0872

Reported adverse events (FAERS/openFDA)#

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