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United States · US · US:71335-1948_32c97d77-42fa-4dee-8597-86e0a08831c4
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
- ndc11713351948060 TABLET in 1 BOTTLE (71335-1948-0)
- ndc1171335194812 TABLET in 1 BOTTLE (71335-1948-1)
- ndc11713351948214 TABLET in 1 BOTTLE (71335-1948-2)
- ndc1171335194833 TABLET in 1 BOTTLE (71335-1948-3)
- ndc1171335194846 TABLET in 1 BOTTLE (71335-1948-4)
- ndc11713351948530 TABLET in 1 BOTTLE (71335-1948-5)
- ndc1171335194868 TABLET in 1 BOTTLE (71335-1948-6)
- ndc1171335194871 TABLET in 1 BOTTLE (71335-1948-7)
- ndc1171335194887 TABLET in 1 BOTTLE (71335-1948-8)
- ndc11713351948910 TABLET in 1 BOTTLE (71335-1948-9)
Annotations
UNII (FDA Substance ID)
8VZV102JFY
FLUCONAZOLE
RxCUI 4450
Orange Book
A078423
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": "71335-1948_32c97d77-42fa-4dee-8597-86e0a08831c4",
"productndc": "71335-1948",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078423",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Mar 7, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "002",
"approval_date": "Mar 7, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "003",
"approval_date": "Mar 7, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "004",
"approval_date": "Mar 7, 2011"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUCONAZOLE",
"proprietary_name": "Fluconazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078423",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluconazole",
"start_marketing_date": "20210422",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code J02AC01.
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