fluconazole

Generic: fluconazole

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

fluconazole 50 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1546
Product ID 67046-1546_325c5d26-634e-9deb-e063-6394a90aacfe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077253
Listing Expiration 2026-12-31
Marketing Start 2025-04-09

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 670461546
Hyphenated Format 67046-1546

Supplemental Identifiers

RxCUI
197701
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
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1546-3)
source: ndc

Packages (1)

67046-1546-3 30 TABLET in 1 BLISTER PACK (67046-1546-3)

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": "325c5d26-634e-9deb-e063-6394a90aacfe", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "unii": ["8VZV102JFY"], "rxcui": ["197701"], "spl_set_id": ["325d5d69-5132-79ea-e063-6294a90afdd0"], "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": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1546-3)", "package_ndc": "67046-1546-3", "marketing_start_date": "20250409"}], "brand_name": "Fluconazole", "product_id": "67046-1546_325c5d26-634e-9deb-e063-6394a90aacfe", "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": "67046-1546", "generic_name": "Fluconazole", "labeler_name": "Coupler LLC", "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": "20250409", "listing_expiration_date": "20261231"}