rezzayo

Generic: rezafungin

Labeler: melinta therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name rezzayo
Generic Name rezafungin
Labeler melinta therapeutics, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

rezafungin 200 mg/1

Manufacturer
Melinta Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70842-240
Product ID 70842-240_a91a59e4-63d3-41fb-abb3-855595981cf8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217417
Listing Expiration 2026-12-31
Marketing Start 2023-06-09

Pharmacologic Class

Established (EPC)
echinocandin antifungal [epc]
Chemical Structure
lipopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70842240
Hyphenated Format 70842-240

Supplemental Identifiers

RxCUI
2639160 2639165
UNII
G013B5478J
NUI
N0000175507 M0519359

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 rezzayo (source: ndc)
Generic Name rezafungin (source: ndc)
Application Number NDA217417 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (70842-240-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
source: ndc

Packages (1)

70842-240-01 1 VIAL in 1 CARTON (70842-240-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Ingredients (1)

rezafungin (200 mg/1)

Linked Drug Pages (1)

REZZAYO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "a91a59e4-63d3-41fb-abb3-855595981cf8", "openfda": {"nui": ["N0000175507", "M0519359"], "unii": ["G013B5478J"], "rxcui": ["2639160", "2639165"], "spl_set_id": ["90073508-6dca-4d27-aa5a-ed837737c35b"], "pharm_class_cs": ["Lipopeptides [CS]"], "pharm_class_epc": ["Echinocandin Antifungal [EPC]"], "manufacturer_name": ["Melinta Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (70842-240-01)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL", "package_ndc": "70842-240-01", "marketing_start_date": "20230609"}], "brand_name": "REZZAYO", "product_id": "70842-240_a91a59e4-63d3-41fb-abb3-855595981cf8", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Echinocandin Antifungal [EPC]", "Lipopeptides [CS]"], "product_ndc": "70842-240", "generic_name": "rezafungin", "labeler_name": "Melinta Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "REZZAYO", "active_ingredients": [{"name": "REZAFUNGIN", "strength": "200 mg/1"}], "application_number": "NDA217417", "marketing_category": "NDA", "marketing_start_date": "20230609", "listing_expiration_date": "20261231"}