ENBUMYST- bumetanide nasal spray spray

Enbumyst by

Drug Labeling and Warnings

Enbumyst by is a Prescription medication manufactured, distributed, or labeled by Renaissance Lakewood LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

instructions for use

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ENBUMYST 
bumetanide nasal spray spray

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 49396-0050
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BUMETANIDE (UNII: 0Y2S3XUQ5H) (BUMETANIDE - UNII:0Y2S3XUQ5H)	BUMETANIDE	0.5 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49396-0050-6	6 in 1 CARTON	09/12/2025
1		1 in 1 BLISTER PACK
1		0.1 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 49396-0050-2	12 in 1 CARTON	09/12/2025
2		1 in 1 BLISTER PACK
2		0.1 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA219500	09/12/2025

Labeler - Renaissance Lakewood LLC (077744035)