fluconazole

Generic: fluconazole

Labeler: direct rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluconazole
Generic Name fluconazole
Labeler direct rx
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fluconazole 200 mg/1

Manufacturer
Direct Rx

Identifiers & Regulatory

Product NDC 61919-493
Product ID 61919-493_0e88c9e2-8dbd-917c-e063-6294a90a6ec9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208963
Listing Expiration 2026-12-31
Marketing Start 2019-04-08

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 61919493
Hyphenated Format 61919-493

Supplemental Identifiers

RxCUI
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 ANDA208963 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 3 TABLET in 1 BOTTLE (61919-493-03)
source: ndc

Packages (1)

61919-493-03 3 TABLET in 1 BOTTLE (61919-493-03)

Ingredients (1)

fluconazole (200 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": "0e88c9e2-8dbd-917c-e063-6294a90a6ec9", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "unii": ["8VZV102JFY"], "rxcui": ["197700"], "spl_set_id": ["69f199fa-bb92-4837-8b12-427a1c71f622"], "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": ["Direct Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "3 TABLET in 1 BOTTLE (61919-493-03)", "package_ndc": "61919-493-03", "marketing_start_date": "20190408"}], "brand_name": "Fluconazole", "product_id": "61919-493_0e88c9e2-8dbd-917c-e063-6294a90a6ec9", "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": "61919-493", "generic_name": "Fluconazole", "labeler_name": "Direct Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluconazole", "active_ingredients": [{"name": "FLUCONAZOLE", "strength": "200 mg/1"}], "application_number": "ANDA208963", "marketing_category": "ANDA", "marketing_start_date": "20190408", "listing_expiration_date": "20261231"}