fluconazole

Generic: fluconazole

Labeler: hospira, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluconazole
Generic Name fluconazole
Labeler hospira, inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

fluconazole 200 mg/100mL

Manufacturer
Hospira, Inc

Identifiers & Regulatory

Product NDC 0409-3435
Product ID 0409-3435_f49a2c6f-6b6f-43a4-8faf-d21b97ccbbf5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079104
Listing Expiration 2026-12-31
Marketing Start 2025-01-06

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 04093435
Hyphenated Format 0409-3435

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 ANDA079104 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/100mL
source: ndc
Packaging
  • 24 POUCH in 1 CARTON (0409-3435-24) / 1 BAG in 1 POUCH (0409-3435-01) / 100 mL in 1 BAG
source: ndc

Packages (1)

0409-3435-24 24 POUCH in 1 CARTON (0409-3435-24) / 1 BAG in 1 POUCH (0409-3435-01) / 100 mL in 1 BAG

Ingredients (1)

fluconazole (200 mg/100mL)

Linked Drug Pages (1)

Fluconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "f49a2c6f-6b6f-43a4-8faf-d21b97ccbbf5", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "unii": ["8VZV102JFY"], "rxcui": ["1721314", "1721315"], "spl_set_id": ["22ebc3fb-ee81-44bd-a6e3-5e759ee724a8"], "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": ["Hospira, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 POUCH in 1 CARTON (0409-3435-24)  / 1 BAG in 1 POUCH (0409-3435-01)  / 100 mL in 1 BAG", "package_ndc": "0409-3435-24", "marketing_start_date": "20250106"}], "brand_name": "Fluconazole", "product_id": "0409-3435_f49a2c6f-6b6f-43a4-8faf-d21b97ccbbf5", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "0409-3435", "generic_name": "Fluconazole", "labeler_name": "Hospira, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluconazole", "active_ingredients": [{"name": "FLUCONAZOLE", "strength": "200 mg/100mL"}], "application_number": "ANDA079104", "marketing_category": "ANDA", "marketing_start_date": "20250106", "listing_expiration_date": "20261231"}