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United States · US · US:59762-5030_5a926244-1653-4a4e-9a60-9713a91d2485
Fluconazole
Orange BookUNIISPLATC J02AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ02AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1159762503011 BOTTLE in 1 CARTON (59762-5030-1) / 35 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
8VZV102JFY
FLUCONAZOLE
RxCUI 4450
Orange Book
N020090
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "8VZV102JFY",
"rxcui": "4450",
"inchikey": "RFHAOTPXVQNOHP-UHFFFAOYSA-N",
"display_name": "FLUCONAZOLE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"2099c3a0-1911-4d4a-878a-36cf054bdd0b": {
"match": "brand_token",
"title": "FLUCONAZOLE TABLET [ASCLEMED USA INC.]",
"spl_version": "2",
"published_date": "2026-05-21"
}
},
"productid": "59762-5030_5a926244-1653-4a4e-9a60-9713a91d2485",
"productndc": "59762-5030",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "020090",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "50MG/5ML",
"product_no": "001",
"approval_date": "Dec 23, 1993"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "200MG/5ML",
"product_no": "002",
"approval_date": "Dec 23, 1993"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUCONAZOLE",
"proprietary_name": "Fluconazole",
"active_ingred_unit": "mg/mL",
"application_number": "NDA020090",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "fluconazole",
"start_marketing_date": "19931223",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code J02AC01.
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