fluconazole

Generic: fluconazole

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluconazole
Generic Name fluconazole
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fluconazole 150 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-209
Product ID 72789-209_32fb9b13-bf4c-10c0-e063-6394a90a0301
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078423
Listing Expiration 2026-12-31
Marketing Start 2021-04-22

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 72789209
Hyphenated Format 72789-209

Supplemental Identifiers

RxCUI
197699
UPC
0372789209029
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 ANDA078423 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 2 TABLET in 1 BOTTLE, PLASTIC (72789-209-02)
  • 1 TABLET in 1 BOTTLE, PLASTIC (72789-209-79)
source: ndc

Packages (2)

72789-209-02 2 TABLET in 1 BOTTLE, PLASTIC (72789-209-02) 72789-209-79 1 TABLET in 1 BOTTLE, PLASTIC (72789-209-79)

Ingredients (1)

fluconazole (150 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": "32fb9b13-bf4c-10c0-e063-6394a90a0301", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "upc": ["0372789209029"], "unii": ["8VZV102JFY"], "rxcui": ["197699"], "spl_set_id": ["d9e772e9-d916-42ae-8020-89b263236102"], "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": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "2 TABLET in 1 BOTTLE, PLASTIC (72789-209-02)", "package_ndc": "72789-209-02", "marketing_start_date": "20211013"}, {"sample": false, "description": "1 TABLET in 1 BOTTLE, PLASTIC (72789-209-79)", "package_ndc": "72789-209-79", "marketing_start_date": "20211013"}], "brand_name": "Fluconazole", "product_id": "72789-209_32fb9b13-bf4c-10c0-e063-6394a90a0301", "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": "72789-209", "generic_name": "Fluconazole", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluconazole", "active_ingredients": [{"name": "FLUCONAZOLE", "strength": "150 mg/1"}], "application_number": "ANDA078423", "marketing_category": "ANDA", "marketing_start_date": "20210422", "listing_expiration_date": "20261231"}