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United States · US · US:71335-1895_0a2b1160-1a6c-414e-91b5-f3d2e3657c1f
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
- ndc1171335189504 TABLET in 1 BOTTLE (71335-1895-0)
- ndc11713351895130 TABLET in 1 BOTTLE (71335-1895-1)
- ndc11713351895212 TABLET in 1 BOTTLE (71335-1895-2)
- ndc117133518953100 TABLET in 1 BOTTLE (71335-1895-3)
- ndc1171335189543 TABLET in 1 BOTTLE (71335-1895-4)
- ndc11713351895528 TABLET in 1 BOTTLE (71335-1895-5)
- ndc1171335189561 TABLET in 1 BOTTLE (71335-1895-6)
- ndc1171335189572 TABLET in 1 BOTTLE (71335-1895-7)
- ndc11713351895814 TABLET in 1 BOTTLE (71335-1895-8)
- ndc1171335189598 TABLET in 1 BOTTLE (71335-1895-9)
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": "71335-1895_0a2b1160-1a6c-414e-91b5-f3d2e3657c1f",
"productndc": "71335-1895",
"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": "200"
}Related drugs
Other records sharing ATC code J02AC01.
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