MICAFUNGIN

Orange BookUNIISPLATC J02AX05

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

Identification

ManufacturerQilu Pharmaceutical Co., Ltd

CountryUS (United States)

ATC codeJ02AX05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6718405891
1 VIAL in 1 CARTON (67184-0589-1) / 5 mL in 1 VIAL
ndc11
6718405892
10 VIAL in 1 CARTON (67184-0589-2) / 5 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

R10H71BSWG

MICAFUNGIN

RxCUI 325887

Orange Book

A219273

APAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "R10H71BSWG",
    "rxcui": "325887",
    "inchikey": "PIEUQSKUWLMALL-YABMTYFHSA-N",
    "display_name": "MICAFUNGIN",
    "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": "67184-0589_0f106cca-1588-4f13-a833-662676fc85c8",
  "productndc": "67184-0589",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "219273",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 50MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Apr 3, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 100MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Apr 3, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MICAFUNGIN",
  "proprietary_name": "MICAFUNGIN",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA219273",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Micafungin",
  "start_marketing_date": "20250403",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code J02AX05.

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