fluconazole

Generic: fluconazole

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluconazole
Generic Name fluconazole
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fluconazole 200 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 55289-824
Product ID 55289-824_2ac0449d-f1fd-33f4-e063-6394a90a9402
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077253
Listing Expiration 2026-12-31
Marketing Start 2006-01-25

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 55289824
Hyphenated Format 55289-824

Supplemental Identifiers

RxCUI
197700
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 ANDA077253 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 20 TABLET in 1 BOTTLE, PLASTIC (55289-824-20)
  • 30 TABLET in 1 BOTTLE, PLASTIC (55289-824-30)
source: ndc

Packages (2)

55289-824-20 20 TABLET in 1 BOTTLE, PLASTIC (55289-824-20) 55289-824-30 30 TABLET in 1 BOTTLE, PLASTIC (55289-824-30)

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": "2ac0449d-f1fd-33f4-e063-6394a90a9402", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "unii": ["8VZV102JFY"], "rxcui": ["197700"], "spl_set_id": ["dd975843-c3e4-44f4-bb0d-33b294c1f6fb"], "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": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (55289-824-20)", "package_ndc": "55289-824-20", "marketing_start_date": "20110520"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (55289-824-30)", "package_ndc": "55289-824-30", "marketing_start_date": "20110520"}], "brand_name": "Fluconazole", "product_id": "55289-824_2ac0449d-f1fd-33f4-e063-6394a90a9402", "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": "55289-824", "generic_name": "Fluconazole", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluconazole", "active_ingredients": [{"name": "FLUCONAZOLE", "strength": "200 mg/1"}], "application_number": "ANDA077253", "marketing_category": "ANDA", "marketing_start_date": "20060125", "listing_expiration_date": "20261231"}