🇺🇸
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
- ndc1125021191101 VIAL in 1 CARTON (25021-191-10) / 5 mL in 1 VIAL
- ndc11250211911110 VIAL in 1 CARTON (25021-191-11) / 5 mL in 1 VIAL
- ndc11250211911220 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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