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United States · US · US:25021-191_edf05767-b6ad-4236-ac59-6c63ec6869f0

Micafungin

Orange BookUNIISPLATC J02AX05

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

Identification

ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeJ02AX05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    2502119110
    1 VIAL in 1 CARTON (25021-191-10) / 5 mL in 1 VIAL
  • ndc11
    2502119111
    10 VIAL in 1 CARTON (25021-191-11) / 5 mL in 1 VIAL
  • ndc11
    2502119112
    20 VIAL in 1 CARTON (25021-191-12) / 5 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
IS1UP79R56
MICAFUNGIN SODIUM
RxCUI 487070
Orange Book
A213363
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": "25021-191_edf05767-b6ad-4236-ac59-6c63ec6869f0",
  "productndc": "25021-191",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "213363",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 50MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Jul 9, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 100MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Jul 9, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MICAFUNGIN SODIUM",
  "proprietary_name": "Micafungin",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA213363",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Micafungin Sodium",
  "start_marketing_date": "20210615",
  "active_numerator_strength": "100"
}

Related drugs

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