Home NDC 84388-005-12 Enbumyst
Product NDC 84388-005
Requested package NDC 84388-005-12
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N219500-001 ENBUMYST BUMETANIDE 0.5MG/SPRAY SPRAY / NASAL RLD, RS 2025-09-12
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N219500-001 11123319 2040-12-04 Drug product 2025-10-03 N219500-001 11260038 2040-12-04 U-4279 2025-10-03 N219500-001 12329731 2040-12-04 U-4279 Drug product 2025-10-03 N219500-001 12558330 2045-05-14 U-4279 Drug product 2026-03-25
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N219500-001 ENBUMYST 0.5MG/SPRAY SPRAY / NASAL RLD, RS 2025-09-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219500-001 ENBUMYST 0.5MG/SPRAY SPRAY / NASAL RLD, RS 2025-09-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219500-001 ENBUMYST 0.5MG/SPRAY SPRAY / NASAL RLD, RS 2025-09-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219500-001 ENBUMYST 0.5MG/SPRAY SPRAY / NASAL RLD, RS 2025-09-12 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219500-001 ENBUMYST 0.5MG/SPRAY SPRAY / NASAL RLD, RS 2025-09-12 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N219500-001 11123319 2040-12-04 Drug product 2025-10-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219500-001 11260038 2040-12-04 U-4279 2025-10-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219500-001 12329731 2040-12-04 U-4279 Drug product 2025-10-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219500-001 12558330 2045-05-14 U-4279 Drug product 2026-03-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219500-001 11123319 2040-12-04 Drug product 2025-10-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219500-001 11260038 2040-12-04 U-4279 2025-10-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219500-001 12329731 2040-12-04 U-4279 Drug product 2025-10-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219500-001 12558330 2045-05-14 U-4279 Drug product 2026-03-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219500-001 11123319 2040-12-04 Drug product 2025-10-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219500-001 11260038 2040-12-04 U-4279 2025-10-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219500-001 12329731 2040-12-04 U-4279 Drug product 2025-10-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219500-001 11123319 2040-12-04 Drug product 2025-10-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219500-001 11260038 2040-12-04 U-4279 2025-10-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219500-001 12329731 2040-12-04 U-4279 Drug product 2025-10-03 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219500-001 11123319 2040-12-04 Drug product 2025-10-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219500-001 11260038 2040-12-04 U-4279 2025-10-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219500-001 12329731 2040-12-04 U-4279 Drug product 2025-10-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219500-001 12558330 2045-05-14 U-4279 Drug product 2026-03-25 a50c72e98297…
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 Ingredient Strength BUMETANIDE .5 mg/.1mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0Y2S3XUQ5H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2724437 Internal RxNorm lookup 2724443 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84388-005-06 Enbumyst 1 in 1 BLISTER PACK SPRAY 1 3 84388-005-06 Enbumyst 6 in 1 CARTON SPRAY 6 3 84388-005-12 Enbumyst 1 in 1 BLISTER PACK SPRAY 1 3 84388-005-12 Enbumyst 12 in 1 CARTON SPRAY 12 3
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84388-005-12 84388000512 2 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-DOSE 2 carton 2025-09-12 No No Current