voriconazole

Generic: voriconazole

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name voriconazole
Generic Name voriconazole
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

voriconazole 10 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-190
Product ID 65219-190_93859f2f-4d62-4b6f-94bc-a3f5d4ed9890
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211099
Listing Expiration 2026-12-31
Marketing Start 2020-12-01

Pharmacologic Class

Established (EPC)
azole antifungal [epc]
Mechanism of Action
cytochrome p450 3a4 inhibitors [moa] cytochrome p450 2c19 inhibitors [moa] cytochrome p450 2c9 inhibitors [moa]
Chemical Structure
azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219190
Hyphenated Format 65219-190

Supplemental Identifiers

RxCUI
351209
UNII
JFU09I87TR
NUI
N0000175487 M0002083 N0000182141 N0000182140 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 voriconazole (source: ndc)
Generic Name voriconazole (source: ndc)
Application Number ANDA211099 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-190-30) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

65219-190-30 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-190-30) / 20 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

voriconazole (10 mg/mL)

Linked Drug Pages (1)

Voriconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "93859f2f-4d62-4b6f-94bc-a3f5d4ed9890", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000182140", "N0000185504"], "unii": ["JFU09I87TR"], "rxcui": ["351209"], "spl_set_id": ["25eb8d91-5abd-4fdb-a331-dacc960a95d9"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "pharm_class_moa": ["Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (65219-190-30)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "65219-190-30", "marketing_start_date": "20201201"}], "brand_name": "Voriconazole", "product_id": "65219-190_93859f2f-4d62-4b6f-94bc-a3f5d4ed9890", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR 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": "65219-190", "generic_name": "Voriconazole", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Voriconazole", "active_ingredients": [{"name": "VORICONAZOLE", "strength": "10 mg/mL"}], "application_number": "ANDA211099", "marketing_category": "ANDA", "marketing_start_date": "20201201", "listing_expiration_date": "20261231"}