fluconazole

Generic: fluconazole

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

fluconazole 200 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-339
Product ID 50268-339_47bacb91-b009-2ce7-e063-6394a90a0eac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077731
Listing Expiration 2027-12-31
Marketing Start 2016-09-09

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 50268339
Hyphenated Format 50268-339

Supplemental Identifiers

RxCUI
197698 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 ANDA077731 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-339-15) / 1 TABLET in 1 BLISTER PACK (50268-339-11)
source: ndc

Packages (1)

50268-339-15 50 BLISTER PACK in 1 BOX (50268-339-15) / 1 TABLET in 1 BLISTER PACK (50268-339-11)

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": "47bacb91-b009-2ce7-e063-6394a90a0eac", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "unii": ["8VZV102JFY"], "rxcui": ["197698", "197700"], "spl_set_id": ["551a5c8f-57eb-2643-12c6-7c700584b49f"], "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": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-339-15)  / 1 TABLET in 1 BLISTER PACK (50268-339-11)", "package_ndc": "50268-339-15", "marketing_start_date": "20160909"}], "brand_name": "Fluconazole", "product_id": "50268-339_47bacb91-b009-2ce7-e063-6394a90a0eac", "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": "50268-339", "generic_name": "Fluconazole", "labeler_name": "AvPAK", "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": "20160909", "listing_expiration_date": "20271231"}