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United States · US · US:70710-1138_538304da-3971-4e3d-9ad3-af8b3dc186c3
fluconazole
Orange BookUNIISPLATC J02AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals (USA) Inc.
CountryUS (United States)
ATC codeJ02AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc117071011381100 TABLET in 1 BOTTLE (70710-1138-1)
- ndc11707101138330 TABLET in 1 BOTTLE (70710-1138-3)
- ndc11707101138410 BLISTER PACK in 1 CARTON (70710-1138-4) / 10 TABLET in 1 BLISTER PACK
- ndc117071011385500 TABLET in 1 BOTTLE (70710-1138-5)
Annotations
UNII (FDA Substance ID)
8VZV102JFY
FLUCONAZOLE
RxCUI 4450
Orange Book
A208963
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": "70710-1138_538304da-3971-4e3d-9ad3-af8b3dc186c3",
"productndc": "70710-1138",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "208963",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Feb 16, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "002",
"approval_date": "Feb 16, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "003",
"approval_date": "Feb 16, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "004",
"approval_date": "Feb 16, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUCONAZOLE",
"proprietary_name": "fluconazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA208963",
"marketing_category": "ANDA",
"nonproprietary_name": "fluconazole",
"start_marketing_date": "20170406",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code J02AC01.
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