MICAFUNGIN

Orange BookUNIISPLATC J02AX05

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

Identification

ManufacturerBiocon Pharma Inc.

CountryUS (United States)

ATC codeJ02AX05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7037707591
10 VIAL, SINGLE-DOSE in 1 CARTON (70377-075-91) / 5 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

IS1UP79R56

MICAFUNGIN SODIUM

RxCUI 487070

Orange Book

A216438

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": "70377-075_94972438-1ece-f99c-c2a5-e29821e7e9d4",
  "productndc": "70377-075",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "216438",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 50MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "May 29, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 100MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "May 29, 2024"
      }
    ],
    "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": "ANDA216438",
  "marketing_category": "ANDA",
  "nonproprietary_name": "micafungin",
  "start_marketing_date": "20250601",
  "active_numerator_strength": "10"
}

Related drugs

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