fluconazole

Generic: fluconazole

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluconazole
Generic Name fluconazole
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

fluconazole 2 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9668
Product ID 0143-9668_a90257a3-d842-4990-81a5-614293e23119
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078698
Listing Expiration 2026-12-31
Marketing Start 2012-01-30

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 01439668
Hyphenated Format 0143-9668

Supplemental Identifiers

RxCUI
1721314 1721315
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 ANDA078698 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 10 CONTAINER in 1 CARTON (0143-9668-10) / 200 mL in 1 CONTAINER (0143-9668-01)
source: ndc

Packages (1)

0143-9668-10 10 CONTAINER in 1 CARTON (0143-9668-10) / 200 mL in 1 CONTAINER (0143-9668-01)

Ingredients (1)

fluconazole (2 mg/mL)

Linked Drug Pages (1)

Fluconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "a90257a3-d842-4990-81a5-614293e23119", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "unii": ["8VZV102JFY"], "rxcui": ["1721314", "1721315"], "spl_set_id": ["d3ca59bd-ae00-48ab-89aa-87c7f56e9989"], "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": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CONTAINER in 1 CARTON (0143-9668-10)  / 200 mL in 1 CONTAINER (0143-9668-01)", "package_ndc": "0143-9668-10", "marketing_start_date": "20120130"}], "brand_name": "Fluconazole", "product_id": "0143-9668_a90257a3-d842-4990-81a5-614293e23119", "dosage_form": "INJECTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "0143-9668", "generic_name": "Fluconazole", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluconazole", "active_ingredients": [{"name": "FLUCONAZOLE", "strength": "2 mg/mL"}], "application_number": "ANDA078698", "marketing_category": "ANDA", "marketing_start_date": "20120130", "listing_expiration_date": "20261231"}