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United States · US · US:25021-184_c643b54a-3aea-4b5a-afb9-fbb2917243fb
Fluconazole
Orange BookUNIISPLATC J02AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeJ02AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11250211848210 POUCH in 1 CARTON (25021-184-82) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
- ndc11250211848710 POUCH in 1 CARTON (25021-184-87) / 1 BAG in 1 POUCH / 200 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
8VZV102JFY
FLUCONAZOLE
RxCUI 4450
Orange Book
A079104
APAP
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": "INTRAVENOUS",
"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": "25021-184_c643b54a-3aea-4b5a-afb9-fbb2917243fb",
"productndc": "25021-184",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "079104",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "200MG/100ML (2MG/ML)",
"product_no": "001",
"approval_date": "Jul 30, 2009"
},
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "400MG/200ML (2MG/ML)",
"product_no": "002",
"approval_date": "Jul 30, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUCONAZOLE",
"proprietary_name": "Fluconazole",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA079104",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluconazole",
"start_marketing_date": "20180115",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code J02AC01.
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