fluconazole

Generic: fluconazole

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluconazole
Generic Name fluconazole
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fluconazole 200 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-030
Product ID 82804-030_fc4fccd8-19d2-4704-afa9-9ce0ab1d2b5f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077731
Listing Expiration 2026-12-31
Marketing Start 2008-10-07

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 82804030
Hyphenated Format 82804-030

Supplemental Identifiers

RxCUI
197700
UPC
0382804030309
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 ANDA077731 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (82804-030-30)
  • 60 TABLET in 1 BOTTLE (82804-030-60)
  • 90 TABLET in 1 BOTTLE (82804-030-90)
source: ndc

Packages (3)

82804-030-30 30 TABLET in 1 BOTTLE (82804-030-30) 82804-030-60 60 TABLET in 1 BOTTLE (82804-030-60) 82804-030-90 90 TABLET in 1 BOTTLE (82804-030-90)

Ingredients (1)

fluconazole (200 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": "fc4fccd8-19d2-4704-afa9-9ce0ab1d2b5f", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "upc": ["0382804030309"], "unii": ["8VZV102JFY"], "rxcui": ["197700"], "spl_set_id": ["fc4fccd8-19d2-4704-afa9-9ce0ab1d2b5f"], "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": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (82804-030-30)", "package_ndc": "82804-030-30", "marketing_start_date": "20231020"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (82804-030-60)", "package_ndc": "82804-030-60", "marketing_start_date": "20231020"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (82804-030-90)", "package_ndc": "82804-030-90", "marketing_start_date": "20231020"}], "brand_name": "Fluconazole", "product_id": "82804-030_fc4fccd8-19d2-4704-afa9-9ce0ab1d2b5f", "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": "82804-030", "generic_name": "Fluconazole", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluconazole", "active_ingredients": [{"name": "FLUCONAZOLE", "strength": "200 mg/1"}], "application_number": "ANDA077731", "marketing_category": "ANDA", "marketing_start_date": "20081007", "listing_expiration_date": "20261231"}