fluconazole

Generic: fluconazole

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

fluconazole 100 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6500
Product ID 0904-6500_a734a240-4f7d-447f-8eb0-19c16465c57a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076658
Listing Expiration 2026-12-31
Marketing Start 2015-06-25

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 09046500
Hyphenated Format 0904-6500

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 ANDA076658 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 CARTON (0904-6500-06) / 1 TABLET in 1 BLISTER PACK
  • 100 BLISTER PACK in 1 CARTON (0904-6500-61) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

0904-6500-06 50 BLISTER PACK in 1 CARTON (0904-6500-06) / 1 TABLET in 1 BLISTER PACK 0904-6500-61 100 BLISTER PACK in 1 CARTON (0904-6500-61) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

fluconazole (100 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": "a734a240-4f7d-447f-8eb0-19c16465c57a", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "unii": ["8VZV102JFY"], "rxcui": ["197698", "197700"], "spl_set_id": ["13184b13-e252-4b4d-a3e2-cfc4ad3d55b7"], "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": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 CARTON (0904-6500-06)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-6500-06", "marketing_start_date": "20150625"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6500-61)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-6500-61", "marketing_start_date": "20150625"}], "brand_name": "Fluconazole", "product_id": "0904-6500_a734a240-4f7d-447f-8eb0-19c16465c57a", "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": "0904-6500", "generic_name": "Fluconazole", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluconazole", "active_ingredients": [{"name": "FLUCONAZOLE", "strength": "100 mg/1"}], "application_number": "ANDA076658", "marketing_category": "ANDA", "marketing_start_date": "20150625", "listing_expiration_date": "20261231"}