Micafungin in Sodium Chloride

Orange BookUNIISPLATC J02AX05

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

Identification

ManufacturerBaxter Healthcare Corporation

CountryUS (United States)

ATC codeJ02AX05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0338905112
12 CARTON in 1 CARTON (0338-9051-12) / 1 BAG in 1 CARTON (0338-9051-01) / 50 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

IS1UP79R56

MICAFUNGIN SODIUM

RxCUI 487070

Orange Book

N216142

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": "0338-9051_c4a06712-4236-4c33-b5ae-77db633e8303",
  "productndc": "0338-9051",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "216142",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 50MG BASE/50ML (EQ 1MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Sep 29, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 100MG BASE/100ML (EQ 1MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Sep 29, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 150MG BASE/150ML (EQ 1MG BASE/ML)",
        "product_no": "003",
        "approval_date": "Sep 29, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MICAFUNGIN SODIUM",
  "proprietary_name": "Micafungin in Sodium Chloride",
  "active_ingred_unit": "mg/50mL",
  "application_number": "NDA216142",
  "marketing_category": "NDA",
  "nonproprietary_name": "Micafungin in Sodium Chloride",
  "start_marketing_date": "20230929",
  "active_numerator_strength": "50"
}

Related drugs

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