fluconazole

Generic: fluconazole

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name fluconazole
Generic Name fluconazole
Labeler mylan pharmaceuticals inc.
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

fluconazole 10 mg/mL

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59762-5029
Product ID 59762-5029_825a44a4-7ec9-4c4a-b04f-7e470831a511
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020090
Listing Expiration 2026-12-31
Marketing Start 1993-12-23

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 597625029
Hyphenated Format 59762-5029

Supplemental Identifiers

RxCUI
197698 197699 197700 197701 310352 310353
UPC
0359762503015 0359762501516 0359762502919
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 NDA020090 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (59762-5029-1) / 35 mL in 1 BOTTLE
source: ndc

Packages (1)

59762-5029-1 1 BOTTLE in 1 CARTON (59762-5029-1) / 35 mL in 1 BOTTLE

Ingredients (1)

fluconazole (10 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": "825a44a4-7ec9-4c4a-b04f-7e470831a511", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "upc": ["0359762503015", "0359762501516", "0359762502919"], "unii": ["8VZV102JFY"], "rxcui": ["197698", "197699", "197700", "197701", "310352", "310353"], "spl_set_id": ["737e0fac-a2d2-4053-a0d7-edbfb6248f69"], "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": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (59762-5029-1)  / 35 mL in 1 BOTTLE", "package_ndc": "59762-5029-1", "marketing_start_date": "19931223"}], "brand_name": "Fluconazole", "product_id": "59762-5029_825a44a4-7ec9-4c4a-b04f-7e470831a511", "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": "59762-5029", "generic_name": "fluconazole", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluconazole", "active_ingredients": [{"name": "FLUCONAZOLE", "strength": "10 mg/mL"}], "application_number": "NDA020090", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "19931223", "listing_expiration_date": "20261231"}