voriconazole

Generic: voriconazole

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name voriconazole
Generic Name voriconazole
Labeler sandoz inc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

voriconazole 10 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-3416
Product ID 0781-3416_c0e24b42-8021-4101-a68d-1735fbf6c6cb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090862
Listing Expiration 2026-12-31
Marketing Start 2012-05-30

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 07813416
Hyphenated Format 0781-3416

Supplemental Identifiers

RxCUI
351209
UPC
0307813416944
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 ANDA090862 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (0781-3416-94) / 20 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

0781-3416-94 1 VIAL, SINGLE-USE in 1 CARTON (0781-3416-94) / 20 mL in 1 VIAL, SINGLE-USE

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": "c0e24b42-8021-4101-a68d-1735fbf6c6cb", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000182140", "N0000185504"], "upc": ["0307813416944"], "unii": ["JFU09I87TR"], "rxcui": ["351209"], "spl_set_id": ["e648a0e4-f324-49dc-a8f6-cf25ff3b2dfe"], "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": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (0781-3416-94)  / 20 mL in 1 VIAL, SINGLE-USE", "package_ndc": "0781-3416-94", "marketing_start_date": "20120530"}], "brand_name": "Voriconazole", "product_id": "0781-3416_c0e24b42-8021-4101-a68d-1735fbf6c6cb", "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": "0781-3416", "generic_name": "Voriconazole", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Voriconazole", "active_ingredients": [{"name": "VORICONAZOLE", "strength": "10 mg/mL"}], "application_number": "ANDA090862", "marketing_category": "ANDA", "marketing_start_date": "20120530", "listing_expiration_date": "20261231"}