Micafungin

Orange BookUNIISPLATC J02AX05

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerPar Health USA, LLC

CountryUS (United States)

ATC codeJ02AX05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4202322910
10 VIAL, SINGLE-DOSE in 1 CARTON (42023-229-10) / 10 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

IS1UP79R56

MICAFUNGIN SODIUM

RxCUI 487070

Orange Book

N212156

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "IS1UP79R56",
    "rxcui": "487070",
    "inchikey": "KOOAFHGJVIVFMZ-WZPXRXMFSA-M",
    "display_name": "MICAFUNGIN SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "653f8c75-b5b8-41ea-8b33-5baad1680bda": {
      "match": "brand_token",
      "title": "MICAFUNGIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [QILU PHARMACEUTICAL CO., LTD]",
      "spl_version": "5",
      "published_date": "2026-05-22"
    }
  },
  "productid": "42023-229_9e300655-e1cc-4f04-9a9e-9b81688368dc",
  "productndc": "42023-229",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "212156",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 50MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Jun 16, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 100MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Jun 16, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MICAFUNGIN SODIUM",
  "proprietary_name": "Micafungin",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA212156",
  "marketing_category": "NDA",
  "nonproprietary_name": "Micafungin",
  "start_marketing_date": "20210801",
  "active_numerator_strength": "10"
}

Related drugs

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