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United States · US · US:71205-283_1410a251-cc08-49a0-b4aa-dfd217bca85b
fluconazole
Orange BookUNIISPLATC J02AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeJ02AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11712052833030 TABLET in 1 BOTTLE (71205-283-30)
- ndc11712052836060 TABLET in 1 BOTTLE (71205-283-60)
- ndc11712052839090 TABLET in 1 BOTTLE (71205-283-90)
Annotations
UNII (FDA Substance ID)
8VZV102JFY
FLUCONAZOLE
RxCUI 4450
Orange Book
A208963
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": "71205-283_1410a251-cc08-49a0-b4aa-dfd217bca85b",
"productndc": "71205-283",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "208963",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Feb 16, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "002",
"approval_date": "Feb 16, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "003",
"approval_date": "Feb 16, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "004",
"approval_date": "Feb 16, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUCONAZOLE",
"proprietary_name": "fluconazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA208963",
"marketing_category": "ANDA",
"nonproprietary_name": "fluconazole",
"start_marketing_date": "20170406",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code J02AC01.
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