FDA.reportPublic FDA data

Enbumyst

Product NDC
84388-005
11-digit product format
843880005
Labeler code
84388
Product ID
84388-005_f23216fe-f3a4-4550-8b47-eaaef86d9356
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

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 Identifiers#

Field, Values table
FieldValues
Unii0Y2S3XUQ5H
Rxcui2724437, 2724443

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 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
84388-005-06843880005066 BLISTER PACK in 1 CARTON (84388-005-06) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE6 blister pack2025-09-12NoNoCurrent
84388-005-128438800051212 BLISTER PACK in 1 CARTON (84388-005-12) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE12 blister pack2025-09-12NoNoCurrent