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United States · US · US:70436-227_2c3342fa-abe7-d6b0-e063-6394a90ad1c0
Fluconazole
Orange BookUNIISPLATC J02AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSlate Run Pharmaceuticals
CountryUS (United States)
ATC codeJ02AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170436227481 BOTTLE in 1 CARTON (70436-227-48) / 35 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
8VZV102JFY
FLUCONAZOLE
RxCUI 4450
Orange Book
A215738
AB
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": "70436-227_2c3342fa-abe7-d6b0-e063-6394a90ad1c0",
"productndc": "70436-227",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "215738",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG/5ML",
"product_no": "001",
"approval_date": "Sep 21, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUCONAZOLE",
"proprietary_name": "Fluconazole",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA215738",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluconazole",
"start_marketing_date": "20240101",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code J02AC01.
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