Enbumyst (Bumetanide Nasal 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]

ENBUMYST- bumetanide nasal spray spray 
Renaissance Lakewood LLC

----------

Enbumyst (Bumetanide Nasal Spray)

instructions for use

Instructions for Use - Enbumyst

Enbumyst Carton Label

ENBUMYST 
bumetanide nasal spray spray
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 49396-0050
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BUMETANIDE (UNII: 0Y2S3XUQ5H) (BUMETANIDE - UNII:0Y2S3XUQ5H) BUMETANIDE0.5 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49396-0050-66 in 1 CARTON09/12/2025
11 in 1 BLISTER PACK
10.1 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC: 49396-0050-212 in 1 CARTON09/12/2025
21 in 1 BLISTER PACK
20.1 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA21950009/12/202509/12/2025
Labeler - Renaissance Lakewood LLC (077744035)

Revised: 1/2026
Document Id: 48734676-fadd-ee0b-e063-6294a90a5d68
Set id: 4409c4a5-2090-7cb3-e063-6394a90a0872
Version: 3
Effective Time: 20260115