fluconazole

Generic: fluconazole

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluconazole
Generic Name fluconazole
Labeler aurobindo pharma limited
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

fluconazole 40 mg/mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-300
Product ID 65862-300_5305f9a9-119f-43e6-a48a-1598094d6c8f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079150
Listing Expiration 2026-12-31
Marketing Start 2009-09-18

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 65862300
Hyphenated Format 65862-300

Supplemental Identifiers

RxCUI
310352 310353
UPC
0365862300355
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 ANDA079150 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (65862-300-35) / 35 mL in 1 BOTTLE
source: ndc

Packages (1)

65862-300-35 1 BOTTLE in 1 CARTON (65862-300-35) / 35 mL in 1 BOTTLE

Ingredients (1)

fluconazole (40 mg/mL)

Linked Drug Pages (1)

Fluconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5305f9a9-119f-43e6-a48a-1598094d6c8f", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "upc": ["0365862300355"], "unii": ["8VZV102JFY"], "rxcui": ["310352", "310353"], "spl_set_id": ["bf588f7e-89de-4b4e-8d33-c1ff2be1b34e"], "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": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65862-300-35)  / 35 mL in 1 BOTTLE", "package_ndc": "65862-300-35", "marketing_start_date": "20090918"}], "brand_name": "Fluconazole", "product_id": "65862-300_5305f9a9-119f-43e6-a48a-1598094d6c8f", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "65862-300", "generic_name": "Fluconazole", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluconazole", "active_ingredients": [{"name": "FLUCONAZOLE", "strength": "40 mg/mL"}], "application_number": "ANDA079150", "marketing_category": "ANDA", "marketing_start_date": "20090918", "listing_expiration_date": "20261231"}