fluconazole

Generic: fluconazole

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluconazole
Generic Name fluconazole
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

fluconazole 2 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-184
Product ID 25021-184_bd560fcb-5efc-48d3-8d2c-e21f2d072215
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079104
Listing Expiration 2026-12-31
Marketing Start 2019-10-15

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 25021184
Hyphenated Format 25021-184

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
  • 2 mg/mL
source: ndc
Packaging
  • 10 POUCH in 1 CARTON (25021-184-66) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
  • 10 POUCH in 1 CARTON (25021-184-67) / 1 BAG in 1 POUCH / 200 mL in 1 BAG
source: ndc

Packages (2)

25021-184-66 10 POUCH in 1 CARTON (25021-184-66) / 1 BAG in 1 POUCH / 100 mL in 1 BAG 25021-184-67 10 POUCH in 1 CARTON (25021-184-67) / 1 BAG in 1 POUCH / 200 mL in 1 BAG

Ingredients (1)

fluconazole (2 mg/mL)

Linked Drug Pages (2)

Fluconazole ndc-match (0.9) Fluconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "bd560fcb-5efc-48d3-8d2c-e21f2d072215", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "unii": ["8VZV102JFY"], "rxcui": ["1721314", "1721315"], "spl_set_id": ["c041227b-dab6-4c29-ab59-d31993d524b2"], "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": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 POUCH in 1 CARTON (25021-184-66)  / 1 BAG in 1 POUCH / 100 mL in 1 BAG", "package_ndc": "25021-184-66", "marketing_start_date": "20191015"}, {"sample": false, "description": "10 POUCH in 1 CARTON (25021-184-67)  / 1 BAG in 1 POUCH / 200 mL in 1 BAG", "package_ndc": "25021-184-67", "marketing_start_date": "20191015"}], "brand_name": "Fluconazole", "product_id": "25021-184_bd560fcb-5efc-48d3-8d2c-e21f2d072215", "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": "25021-184", "generic_name": "Fluconazole", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluconazole", "active_ingredients": [{"name": "FLUCONAZOLE", "strength": "2 mg/mL"}], "application_number": "ANDA079104", "marketing_category": "ANDA", "marketing_start_date": "20191015", "listing_expiration_date": "20261231"}