🇺🇸
United States · US · US:65862-299_5305f9a9-119f-43e6-a48a-1598094d6c8f
Fluconazole
Orange BookUNIISPLATC J02AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeJ02AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1165862299351 BOTTLE in 1 CARTON (65862-299-35) / 35 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
8VZV102JFY
FLUCONAZOLE
RxCUI 4450
Orange Book
A079150
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": "65862-299_5305f9a9-119f-43e6-a48a-1598094d6c8f",
"productndc": "65862-299",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "079150",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG/5ML",
"product_no": "001",
"approval_date": "Sep 18, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG/5ML",
"product_no": "002",
"approval_date": "Sep 18, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUCONAZOLE",
"proprietary_name": "Fluconazole",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA079150",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluconazole",
"start_marketing_date": "20090918",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code J02AC01.
Access this data programmatically
Query Fluconazole and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.