fluconazole

Generic: fluconazole

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluconazole
Generic Name fluconazole
Labeler asclemed usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fluconazole 150 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-164
Product ID 76420-164_d964ddff-cfca-92ad-e053-2995a90a6568
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077253
Listing Expiration 2026-12-31
Marketing Start 2020-11-20

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 76420164
Hyphenated Format 76420-164

Supplemental Identifiers

RxCUI
197699
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 ANDA077253 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 1 TABLET in 1 BLISTER PACK (76420-164-01)
source: ndc

Packages (1)

76420-164-01 1 TABLET in 1 BLISTER PACK (76420-164-01)

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": "d964ddff-cfca-92ad-e053-2995a90a6568", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "unii": ["8VZV102JFY"], "rxcui": ["197699"], "spl_set_id": ["56a9de97-bbb9-4210-9ace-f77317d5f33b"], "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": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 TABLET in 1 BLISTER PACK (76420-164-01)", "package_ndc": "76420-164-01", "marketing_start_date": "20220304"}], "brand_name": "Fluconazole", "product_id": "76420-164_d964ddff-cfca-92ad-e053-2995a90a6568", "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": "76420-164", "generic_name": "Fluconazole", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluconazole", "active_ingredients": [{"name": "FLUCONAZOLE", "strength": "150 mg/1"}], "application_number": "ANDA077253", "marketing_category": "ANDA", "marketing_start_date": "20201120", "listing_expiration_date": "20261231"}