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United States · US · US:68788-8526_b6d6f745-a593-40dd-9782-4783ed72e85f
Fluconazole
Orange BookUNIISPLATC J02AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ02AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc1168788852601 TABLET in 1 BOTTLE (68788-8526-0)
- ndc11687888526110 TABLET in 1 BOTTLE (68788-8526-1)
- ndc11687888526220 TABLET in 1 BOTTLE (68788-8526-2)
- ndc11687888526330 TABLET in 1 BOTTLE (68788-8526-3)
- ndc11687888526660 TABLET in 1 BOTTLE (68788-8526-6)
- ndc1168788852682 TABLET in 1 BOTTLE (68788-8526-8)
- ndc11687888526990 TABLET in 1 BOTTLE (68788-8526-9)
Annotations
UNII (FDA Substance ID)
8VZV102JFY
FLUCONAZOLE
RxCUI 4450
Orange Book
A077731
ABABABAB
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": "68788-8526_b6d6f745-a593-40dd-9782-4783ed72e85f",
"productndc": "68788-8526",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "077731",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Oct 7, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "002",
"approval_date": "Oct 7, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "003",
"approval_date": "Oct 7, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "004",
"approval_date": "Oct 7, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUCONAZOLE",
"proprietary_name": "Fluconazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077731",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluconazole",
"start_marketing_date": "20230920",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code J02AC01.
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