Micafungin

Orange BookUNIISPLATC J02AX05

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeJ02AX05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7071017251
1 VIAL in 1 CARTON (70710-1725-1) / 5 mL in 1 VIAL
ndc11
7071017256
10 VIAL in 1 CARTON (70710-1725-6) / 5 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

IS1UP79R56

MICAFUNGIN SODIUM

RxCUI 487070

Orange Book

A215241

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": "70710-1725_ae363dc7-b3b5-41e8-8f04-82e30cf3c718",
  "productndc": "70710-1725",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "215241",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 50MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Oct 24, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 100MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Oct 24, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MICAFUNGIN SODIUM",
  "proprietary_name": "Micafungin",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA215241",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Micafungin",
  "start_marketing_date": "20230410",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code J02AX05.

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