fluconazole

Generic: fluconazole

Labeler: zhejiang poly pharm. co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluconazole
Generic Name fluconazole
Labeler zhejiang poly pharm. co., ltd.
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

fluconazole 40 mg/mL

Manufacturer
Zhejiang Poly Pharm. Co., Ltd.

Identifiers & Regulatory

Product NDC 72673-091
Product ID 72673-091_47d8769c-b294-65ab-e063-6394a90a8bff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215738
Listing Expiration 2027-12-31
Marketing Start 2025-04-01

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 72673091
Hyphenated Format 72673-091

Supplemental Identifiers

RxCUI
310353
UPC
0372673091143
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 ANDA215738 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (72673-091-14) / 35 mL in 1 BOTTLE
source: ndc

Packages (1)

72673-091-14 1 BOTTLE in 1 CARTON (72673-091-14) / 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": "47d8769c-b294-65ab-e063-6394a90a8bff", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "upc": ["0372673091143"], "unii": ["8VZV102JFY"], "rxcui": ["310353"], "spl_set_id": ["2a3ba181-5baa-5942-e063-6294a90a82b2"], "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": ["Zhejiang Poly Pharm. Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (72673-091-14)  / 35 mL in 1 BOTTLE", "package_ndc": "72673-091-14", "marketing_start_date": "20250401"}], "brand_name": "Fluconazole", "product_id": "72673-091_47d8769c-b294-65ab-e063-6394a90a8bff", "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": "72673-091", "generic_name": "Fluconazole", "labeler_name": "Zhejiang Poly Pharm. Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluconazole", "active_ingredients": [{"name": "FLUCONAZOLE", "strength": "40 mg/mL"}], "application_number": "ANDA215738", "marketing_category": "ANDA", "marketing_start_date": "20250401", "listing_expiration_date": "20271231"}