Micafungin

Orange BookUNIISPLATC J02AX05

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

Identification

ManufacturerHisun Pharmaceuticals USA, Inc.

CountryUS (United States)

ATC codeJ02AX05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4265802201
1 VIAL in 1 BOX (42658-022-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
ndc11
4265802202
10 BOX in 1 CARTON (42658-022-02) / 1 VIAL in 1 BOX / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Annotations

UNII (FDA Substance ID)

IS1UP79R56

MICAFUNGIN SODIUM

RxCUI 487070

Orange Book

A219712

APAP

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": "42658-022_4f4d74bd-7d4e-0340-e063-6394a90aee8a",
  "productndc": "42658-022",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "219712",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 50MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Jan 21, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 100MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Jan 21, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MICAFUNGIN SODIUM",
  "proprietary_name": "Micafungin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA219712",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Micafungin",
  "start_marketing_date": "20260401",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code J02AX05.

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