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United States · US · US:70771-1065_4813fe26-a1f0-4782-a210-c669ae1ad899
fluconazole
Orange BookUNIISPLATC J02AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeJ02AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc117077110651100 TABLET in 1 BOTTLE (70771-1065-1)
- ndc11707711065330 TABLET in 1 BOTTLE (70771-1065-3)
- ndc117077110655500 TABLET in 1 BOTTLE (70771-1065-5)
- ndc1170771106571 BLISTER PACK in 1 CARTON (70771-1065-7) / 1 TABLET in 1 BLISTER PACK
- ndc11707711065812 BLISTER PACK in 1 CARTON (70771-1065-8) / 1 TABLET in 1 BLISTER PACK
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": "70771-1065_4813fe26-a1f0-4782-a210-c669ae1ad899",
"productndc": "70771-1065",
"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": "150"
}Related drugs
Other records sharing ATC code J02AC01.
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