fluconazole

Generic: fluconazole

Labeler: sportpharm, inc. dba sportpharm
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluconazole
Generic Name fluconazole
Labeler sportpharm, inc. dba sportpharm
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fluconazole 50 mg/1

Manufacturer
Sportpharm, Inc. dba Sportpharm

Identifiers & Regulatory

Product NDC 85766-101
Product ID 85766-101_40c83fbb-16df-1ff7-e063-6394a90a4996
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076658
Listing Expiration 2026-12-31
Marketing Start 2014-06-20

Pharmacologic Class

Established (EPC)
azole antifungal [epc]
Mechanism of Action
cytochrome p450 2c19 inhibitors [moa] cytochrome p450 3a4 inhibitors [moa] cytochrome p450 2c9 inhibitors [moa]
Chemical Structure
azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85766101
Hyphenated Format 85766-101

Supplemental Identifiers

RxCUI
197698 197699 197700 197701
UNII
8VZV102JFY
NUI
N0000175487 M0002083 N0000182140 N0000182141 N0000185504

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fluconazole (source: ndc)
Generic Name fluconazole (source: ndc)
Application Number ANDA076658 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 10 DOSE PACK in 1 CARTON (85766-101-00) / 10 TABLET in 1 DOSE PACK
  • 100 TABLET in 1 BOTTLE (85766-101-01)
  • 500 TABLET in 1 BOTTLE (85766-101-05)
  • 10 TABLET in 1 BOTTLE (85766-101-10)
  • 12 TABLET in 1 BOTTLE (85766-101-12)
  • 20 TABLET in 1 BOTTLE (85766-101-20)
  • 30 TABLET in 1 BOTTLE (85766-101-30)
  • 60 TABLET in 1 BOTTLE (85766-101-60)
  • 90 TABLET in 1 BOTTLE (85766-101-90)
source: ndc

Packages (9)

85766-101-00 10 DOSE PACK in 1 CARTON (85766-101-00) / 10 TABLET in 1 DOSE PACK 85766-101-01 100 TABLET in 1 BOTTLE (85766-101-01) 85766-101-05 500 TABLET in 1 BOTTLE (85766-101-05) 85766-101-10 10 TABLET in 1 BOTTLE (85766-101-10) 85766-101-12 12 TABLET in 1 BOTTLE (85766-101-12) 85766-101-20 20 TABLET in 1 BOTTLE (85766-101-20) 85766-101-30 30 TABLET in 1 BOTTLE (85766-101-30) 85766-101-60 60 TABLET in 1 BOTTLE (85766-101-60) 85766-101-90 90 TABLET in 1 BOTTLE (85766-101-90)

Ingredients (1)

fluconazole (50 mg/1)

Linked Drug Pages (1)

Fluconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40c83fbb-16df-1ff7-e063-6394a90a4996", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "unii": ["8VZV102JFY"], "rxcui": ["197698", "197699", "197700", "197701"], "spl_set_id": ["8a4d6d9e-02ae-42e4-83ec-f5c4e135273b"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "pharm_class_moa": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]"], "manufacturer_name": ["Sportpharm, Inc. dba Sportpharm"]}, "finished": true, "packaging": [{"sample": false, "description": "10 DOSE PACK in 1 CARTON (85766-101-00)  / 10 TABLET in 1 DOSE PACK", "package_ndc": "85766-101-00", "marketing_start_date": "20251010"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (85766-101-01)", "package_ndc": "85766-101-01", "marketing_start_date": "20251010"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (85766-101-05)", "package_ndc": "85766-101-05", "marketing_start_date": "20251010"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (85766-101-10)", "package_ndc": "85766-101-10", "marketing_start_date": "20251010"}, {"sample": false, "description": "12 TABLET in 1 BOTTLE (85766-101-12)", "package_ndc": "85766-101-12", "marketing_start_date": "20251010"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (85766-101-20)", "package_ndc": "85766-101-20", "marketing_start_date": "20251010"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (85766-101-30)", "package_ndc": "85766-101-30", "marketing_start_date": "20251010"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (85766-101-60)", "package_ndc": "85766-101-60", "marketing_start_date": "20251010"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (85766-101-90)", "package_ndc": "85766-101-90", "marketing_start_date": "20251010"}], "brand_name": "Fluconazole", "product_id": "85766-101_40c83fbb-16df-1ff7-e063-6394a90a4996", "dosage_form": "TABLET", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "85766-101", "generic_name": "Fluconazole", "labeler_name": "Sportpharm, Inc. dba Sportpharm", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluconazole", "active_ingredients": [{"name": "FLUCONAZOLE", "strength": "50 mg/1"}], "application_number": "ANDA076658", "marketing_category": "ANDA", "marketing_start_date": "20140620", "listing_expiration_date": "20261231"}