fluconazole

Generic: fluconazole

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluconazole
Generic Name fluconazole
Labeler bluepoint laboratories
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fluconazole 50 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-251
Product ID 68001-251_472a93c7-fd2a-f837-e063-6294a90aed1b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077253
Listing Expiration 2026-12-31
Marketing Start 2014-03-13

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 68001251
Hyphenated Format 68001-251

Supplemental Identifiers

RxCUI
197698 197699 197700 197701
UPC
0368001252041 0368001251044 0368001253444 0368001254045
UNII
8VZV102JFY
NUI
N0000175487 M0002083 N0000182140 N0000182141 N0000185504

Packaging Origin

Original Packager
true

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
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68001-251-04)
source: ndc

Packages (1)

68001-251-04 30 TABLET in 1 BOTTLE (68001-251-04)

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": "472a93c7-fd2a-f837-e063-6294a90aed1b", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "upc": ["0368001252041", "0368001251044", "0368001253444", "0368001254045"], "unii": ["8VZV102JFY"], "rxcui": ["197698", "197699", "197700", "197701"], "spl_set_id": ["83bcb8fc-53f1-4d7b-b083-0905b52c6c7e"], "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": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68001-251-04)", "package_ndc": "68001-251-04", "marketing_start_date": "20140313"}], "brand_name": "Fluconazole", "product_id": "68001-251_472a93c7-fd2a-f837-e063-6294a90aed1b", "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": "68001-251", "generic_name": "Fluconazole", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluconazole", "active_ingredients": [{"name": "FLUCONAZOLE", "strength": "50 mg/1"}], "application_number": "ANDA077253", "marketing_category": "ANDA", "marketing_start_date": "20140313", "listing_expiration_date": "20261231"}