FDA.reportPublic FDA data

Enbumyst

Product NDC
84388-005
11-digit product format
843880005
Labeler code
84388
Product ID
84388-005_36587302-f02b-4a6c-a5f5-be52ea98c8d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bumetanide
Dosage form
SPRAY
Route
NASAL
Labeler
Corstasis USA LLC
Application
NDA219500
Marketing category
NDA
Marketing start
2025-09-12
Substance
BUMETANIDE
Active strength
.5 mg/.1mL
Pharmacologic classes
Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage84388-00584388-005-06DDiscontinued by firm2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219500-001ENBUMYSTBUMETANIDE0.5MG/SPRAYSPRAY / NASALRLD, RS2025-09-12

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219500-001111233192040-12-04Drug product2025-10-03
N219500-001112600382040-12-04U-42792025-10-03
N219500-001123297312040-12-04U-4279Drug product2025-10-03
N219500-001125583302045-05-14U-4279Drug product2026-03-25

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N219500-001ENBUMYST0.5MG/SPRAYSPRAY / NASALRLD, RS2025-09-1284e616aacf4f…
2026-08-18 06:07:402026-07N219500-001ENBUMYST0.5MG/SPRAYSPRAY / NASALRLD, RS2025-09-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219500-001ENBUMYST0.5MG/SPRAYSPRAY / NASALRLD, RS2025-09-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219500-001ENBUMYST0.5MG/SPRAYSPRAY / NASALRLD, RS2025-09-1231067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219500-001ENBUMYST0.5MG/SPRAYSPRAY / NASALRLD, RS2025-09-12a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N219500-001111233192040-12-04Drug product2025-10-0384e616aacf4f…
2026-09-14 22:38:342026-08N219500-001112600382040-12-04U-42792025-10-0384e616aacf4f…
2026-09-14 22:38:342026-08N219500-001123297312040-12-04U-4279Drug product2025-10-0384e616aacf4f…
2026-09-14 22:38:342026-08N219500-001125583302045-05-14U-4279Drug product2026-03-2584e616aacf4f…
2026-08-18 06:07:402026-07N219500-001111233192040-12-04Drug product2025-10-03caaa826d4ba7…
2026-08-18 06:07:402026-07N219500-001112600382040-12-04U-42792025-10-03caaa826d4ba7…
2026-08-18 06:07:402026-07N219500-001123297312040-12-04U-4279Drug product2025-10-03caaa826d4ba7…
2026-08-18 06:07:402026-07N219500-001125583302045-05-14U-4279Drug product2026-03-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219500-001111233192040-12-04Drug product2025-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219500-001112600382040-12-04U-42792025-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219500-001123297312040-12-04U-4279Drug product2025-10-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219500-001111233192040-12-04Drug product2025-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219500-001112600382040-12-04U-42792025-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219500-001123297312040-12-04U-4279Drug product2025-10-0331067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219500-001111233192040-12-04Drug product2025-10-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219500-001112600382040-12-04U-42792025-10-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219500-001123297312040-12-04U-4279Drug product2025-10-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219500-001125583302045-05-14U-4279Drug product2026-03-25a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Enbumyst
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUMETANIDE.5 mg/.1mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0Y2S3XUQ5HInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2724437Internal RxNorm lookup
2724443Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d6f752c5-d2bd-4f77-9611-ca2110066d1fAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84388-005-06Enbumyst1 in 1 BLISTER PACKSPRAY13
84388-005-06Enbumyst6 in 1 CARTONSPRAY63
84388-005-12Enbumyst1 in 1 BLISTER PACKSPRAY13
84388-005-12Enbumyst12 in 1 CARTONSPRAY123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84388-005-06EA - Each84388-00559ee0432-4604-4290-8b2e-24e171d9501112026-05-22
84388-005-12EA - Each84388-0053a605381-c752-4e0e-a4a7-6a34679015fe12025-10-14

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EnbumystBUMETANIDECorstasis USA LLCd6f752c5-d2bd-4f77-9611-ca2110066d1f2026-08-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 219500
application number: NDA219500
ndc (product): 84388-005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2724437bumetanide 0.5 MG in 0.1 ML Nasal SprayPSNd6f752c5-d2bd-4f77-9611-ca2110066d1f3
2724443Enbumyst 0.5 MG in 0.1 ML Nasal SprayPSNd6f752c5-d2bd-4f77-9611-ca2110066d1f3
2724443bumetanide 5 MG/ML Nasal Spray [Enbumyst]SBDd6f752c5-d2bd-4f77-9611-ca2110066d1f3
2724437bumetanide 5 MG/ML Nasal SpraySCDd6f752c5-d2bd-4f77-9611-ca2110066d1f3
2724437bumetanide 0.5 MG per 0.1 ML Nasal SpraySYd6f752c5-d2bd-4f77-9611-ca2110066d1f3
2724443Enbumyst 0.5 MG per 0.1 ML Nasal SpraySYd6f752c5-d2bd-4f77-9611-ca2110066d1f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84388-005-06843880005061 in 1 BLISTER PACKHistorical
84388-005-12843880005122 CARTON in 1 CARTON (84388-005-12) / 6 PACKAGE in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 PACKAGE / .1 mL in 1 VIAL, SINGLE-DOSE2 carton2025-09-12NoNoCurrent