fluconazole

Generic: fluconazole

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

fluconazole 200 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-516
Product ID 72189-516_2c4e6424-181d-1db8-e063-6294a90a52d9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077731
Listing Expiration 2026-12-31
Marketing Start 2023-10-05

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 72189516
Hyphenated Format 72189-516

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 ANDA077731 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 3 TABLET in 1 BOTTLE (72189-516-03)
source: ndc

Packages (1)

72189-516-03 3 TABLET in 1 BOTTLE (72189-516-03)

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": "2c4e6424-181d-1db8-e063-6294a90a52d9", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "unii": ["8VZV102JFY"], "rxcui": ["197700"], "spl_set_id": ["06f8f4b9-5289-2d59-e063-6294a90a7209"], "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": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "3 TABLET in 1 BOTTLE (72189-516-03)", "package_ndc": "72189-516-03", "marketing_start_date": "20231005"}], "brand_name": "Fluconazole", "product_id": "72189-516_2c4e6424-181d-1db8-e063-6294a90a52d9", "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": "72189-516", "generic_name": "Fluconazole", "labeler_name": "Direct_Rx", "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": "20231005", "listing_expiration_date": "20261231"}