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United States · US · US:0049-3450_c835d7dd-af65-4b2c-a92c-42d1986f902d
Diflucan
Orange BookUNIISPLATC J02AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRoerig
CountryUS (United States)
ATC codeJ02AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1100493450191 BOTTLE in 1 CARTON (0049-3450-19) / 35 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
8VZV102JFY
FLUCONAZOLE
RxCUI 4450
Orange Book
N020090
ABAB
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": {
"f694c617-3383-416c-91b6-b94fda371204": {
"match": "brand_token",
"title": "DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]",
"spl_version": "57",
"published_date": "2026-04-09"
}
},
"productid": "0049-3450_c835d7dd-af65-4b2c-a92c-42d1986f902d",
"productndc": "0049-3450",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "020090",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "50MG/5ML",
"product_no": "001",
"approval_date": "Dec 23, 1993"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "200MG/5ML",
"product_no": "002",
"approval_date": "Dec 23, 1993"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUCONAZOLE",
"proprietary_name": "Diflucan",
"active_ingred_unit": "mg/35mL",
"application_number": "NDA020090",
"marketing_category": "NDA",
"nonproprietary_name": "fluconazole",
"start_marketing_date": "19931223",
"active_numerator_strength": "1400"
}Related drugs
Other records sharing ATC code J02AC01.
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