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United States · US · US:70842-240_2b7bcdc0-0333-42a1-942c-7b2efeb2398a

REZZAYO

Orange BookUNIISPLATC J02AX

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerMelinta Therapeutics, LLC
CountryUS (United States)
ATC codeJ02AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7084224001
    1 VIAL in 1 CARTON (70842-240-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Annotations

UNII (FDA Substance ID)
G013B5478J
REZAFUNGIN
Orange Book
N217417
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "G013B5478J",
    "rxcui": null,
    "inchikey": "LNFCWEXGZIEGJW-TXSVMFMRSA-O",
    "display_name": "REZAFUNGIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "90073508-6dca-4d27-aa5a-ed837737c35b": {
      "match": "brand_token",
      "title": "REZZAYO (REZAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MELINTA THERAPEUTICS, LLC]",
      "spl_version": "4",
      "published_date": "2026-03-16"
    }
  },
  "productid": "70842-240_2b7bcdc0-0333-42a1-942c-7b2efeb2398a",
  "productndc": "70842-240",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "217417",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 200MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Mar 22, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "REZAFUNGIN",
  "proprietary_name": "REZZAYO",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA217417",
  "marketing_category": "NDA",
  "nonproprietary_name": "rezafungin",
  "start_marketing_date": "20230609",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code J02AX.

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