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United States · US · US:71335-0686_9734dcd0-c8ba-455b-89fa-e78063597742
fluconazole
Orange BookUNIISPLATC J02AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeJ02AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 10
- ndc11713350686060 TABLET in 1 BOTTLE (71335-0686-0)
- ndc1171335068612 TABLET in 1 BOTTLE (71335-0686-1)
- ndc11713350686214 TABLET in 1 BOTTLE (71335-0686-2)
- ndc1171335068633 TABLET in 1 BOTTLE (71335-0686-3)
- ndc1171335068646 TABLET in 1 BOTTLE (71335-0686-4)
- ndc11713350686530 TABLET in 1 BOTTLE (71335-0686-5)
- ndc1171335068668 TABLET in 1 BOTTLE (71335-0686-6)
- ndc1171335068671 TABLET in 1 BOTTLE (71335-0686-7)
- ndc1171335068687 TABLET in 1 BOTTLE (71335-0686-8)
- ndc11713350686910 TABLET in 1 BOTTLE (71335-0686-9)
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": "71335-0686_9734dcd0-c8ba-455b-89fa-e78063597742",
"productndc": "71335-0686",
"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": "100"
}Related drugs
Other records sharing ATC code J02AC01.
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