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United States · US · US:0338-6046_36e35cdf-c4a0-428a-879e-1d65e2b66f64
Fluconazole
Orange BookUNIISPLATC J02AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBaxter Healthcare Company
CountryUS (United States)
ATC codeJ02AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11033860464810 BAG in 1 CARTON (0338-6046-48) / 100 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
8VZV102JFY
FLUCONAZOLE
RxCUI 4450
Orange Book
A076766
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": "0338-6046_36e35cdf-c4a0-428a-879e-1d65e2b66f64",
"productndc": "0338-6046",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "076766",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "200MG/100ML (2MG/ML)",
"product_no": "001",
"approval_date": "Jul 29, 2004"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "400MG/200ML (2MG/ML)",
"product_no": "002",
"approval_date": "Jul 29, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUCONAZOLE",
"proprietary_name": "Fluconazole",
"active_ingred_unit": "mg/100mL",
"application_number": "ANDA076766",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluconazole",
"start_marketing_date": "20040729",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code J02AC01.
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