enbumyst

Generic: bumetanide

Labeler: corstasis usa llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name enbumyst
Generic Name bumetanide
Labeler corstasis usa llc
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

bumetanide .5 mg/.1mL

Manufacturer
Corstasis USA LLC

Identifiers & Regulatory

Product NDC 84388-005
Product ID 84388-005_f23216fe-f3a4-4550-8b47-eaaef86d9356
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA219500
Listing Expiration 2027-12-31
Marketing Start 2025-09-12

Pharmacologic Class

Established (EPC)
loop diuretic [epc]
Physiologic Effect
increased diuresis at loop of henle [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84388005
Hyphenated Format 84388-005

Supplemental Identifiers

RxCUI
2724437 2724443
UNII
0Y2S3XUQ5H
NUI
N0000175366 N0000175590

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name enbumyst (source: ndc)
Generic Name bumetanide (source: ndc)
Application Number NDA219500 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/.1mL
source: ndc
Packaging
  • 6 BLISTER PACK in 1 CARTON (84388-005-06) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE
  • 12 BLISTER PACK in 1 CARTON (84388-005-12) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

84388-005-06 6 BLISTER PACK in 1 CARTON (84388-005-06) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE 84388-005-12 12 BLISTER PACK in 1 CARTON (84388-005-12) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

bumetanide (.5 mg/.1mL)

Linked Drug Pages (1)

Enbumyst ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "f23216fe-f3a4-4550-8b47-eaaef86d9356", "openfda": {"nui": ["N0000175366", "N0000175590"], "unii": ["0Y2S3XUQ5H"], "rxcui": ["2724437", "2724443"], "spl_set_id": ["d6f752c5-d2bd-4f77-9611-ca2110066d1f"], "pharm_class_pe": ["Increased Diuresis at Loop of Henle [PE]"], "pharm_class_epc": ["Loop Diuretic [EPC]"], "manufacturer_name": ["Corstasis USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BLISTER PACK in 1 CARTON (84388-005-06)  / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "84388-005-06", "marketing_start_date": "20250912"}, {"sample": false, "description": "12 BLISTER PACK in 1 CARTON (84388-005-12)  / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "84388-005-12", "marketing_start_date": "20250912"}], "brand_name": "Enbumyst", "product_id": "84388-005_f23216fe-f3a4-4550-8b47-eaaef86d9356", "dosage_form": "SPRAY", "pharm_class": ["Increased Diuresis at Loop of Henle [PE]", "Loop Diuretic [EPC]"], "product_ndc": "84388-005", "generic_name": "bumetanide", "labeler_name": "Corstasis USA LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Enbumyst", "active_ingredients": [{"name": "BUMETANIDE", "strength": ".5 mg/.1mL"}], "application_number": "NDA219500", "marketing_category": "NDA", "marketing_start_date": "20250912", "listing_expiration_date": "20271231"}