fluconazole in sodium chloride

Generic: fluconazole in sodium chloride

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

Drug Facts

Product Profile

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

fluconazole 2 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-4688
Product ID 0409-4688_a75c6ed9-07f1-4527-82f8-b9a53427a746
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076303
Listing Expiration 2026-12-31
Marketing Start 2006-04-17

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 04094688
Hyphenated Format 0409-4688

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 in sodium chloride (source: ndc)
Generic Name fluconazole in sodium chloride (source: ndc)
Application Number ANDA076303 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 24 BAG in 1 CASE (0409-4688-12) / 200 mL in 1 BAG (0409-4688-16)
  • 24 BAG in 1 CASE (0409-4688-18) / 100 mL in 1 BAG (0409-4688-22)
source: ndc

Packages (2)

0409-4688-12 24 BAG in 1 CASE (0409-4688-12) / 200 mL in 1 BAG (0409-4688-16) 0409-4688-18 24 BAG in 1 CASE (0409-4688-18) / 100 mL in 1 BAG (0409-4688-22)

Ingredients (1)

fluconazole (2 mg/mL)

Linked Drug Pages (1)

Fluconazole in Sodium Chloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "a75c6ed9-07f1-4527-82f8-b9a53427a746", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "unii": ["8VZV102JFY"], "rxcui": ["1721314", "1721315"], "spl_set_id": ["b3efaffa-9ef9-4a4f-998e-aa7d2eb61fc9"], "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 BAG in 1 CASE (0409-4688-12)  / 200 mL in 1 BAG (0409-4688-16)", "package_ndc": "0409-4688-12", "marketing_start_date": "20151021"}, {"sample": false, "description": "24 BAG in 1 CASE (0409-4688-18)  / 100 mL in 1 BAG (0409-4688-22)", "package_ndc": "0409-4688-18", "marketing_start_date": "20151218"}], "brand_name": "Fluconazole in Sodium Chloride", "product_id": "0409-4688_a75c6ed9-07f1-4527-82f8-b9a53427a746", "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": "0409-4688", "generic_name": "Fluconazole in Sodium Chloride", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluconazole in Sodium Chloride", "active_ingredients": [{"name": "FLUCONAZOLE", "strength": "2 mg/mL"}], "application_number": "ANDA076303", "marketing_category": "ANDA", "marketing_start_date": "20060417", "listing_expiration_date": "20261231"}