Voriconazole tablets are contraindicated in patients with known hypersensitivity to voriconazole or their excipients. This formulation utilizes a tablet, film coated delivery system. Marketed by Safecor Health Llc, this product is identified by NDC 48433-147 and is authorized under FDA application ANDA090547.
Identification & Billing
NDC Package Code
48433-147-03
Package Description
30 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-147-01)
11-Digit Billing Format
48433014703
Clinical Specifications
Proprietary Name
Voriconazole
Non-Proprietary Name
Voriconazole
Substance Name
Voriconazole
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Usage Information
Voriconazole tablets are contraindicated in patients with known hypersensitivity to voriconazole or their excipients. There is no information regarding cross-sensitivity between voriconazole and other azole antifungal agents. Caution should be used when prescribing voriconazole tablets to patients with hypersensitivity to other azoles.Coadministration of pimozide, quinidine or ivabradine with voriconazole tablets is contraindicated because increased plasma concentrations of these drugs can lead to QT prolongation and rare occurrences of
torsade de pointes
[see
Drug Interactions (7)]
.
Coadministration of voriconazole tablets with sirolimus is contraindicated because voriconazole tablets significantly increase sirolimus concentrations
[see
Drug Interactions (7)and
Clinical Pharmacology (12.3)]
.
Coadministration of voriconazole tablets with rifampin, carbamazepine, long-acting barbiturates or St John’s Wort is contraindicated because these drugs are likely to decrease plasma voriconazole concentrations significantly
[see
Drug Interactions (7)and
Clinical Pharmacology (12.3)]
.
Coadministration of standard doses of voriconazole with efavirenz doses of 400 mg every 24 hours or higher is contraindicated, because efavirenz significantly decreases plasma voriconazole concentrations in healthy subjects at these doses. Voriconazole also significantly increases efavirenz plasma concentrations
[see
Drug Interactions (7)and
Clinical Pharmacology (12.3)]
.
Coadministration of voriconazole tablets with high-dose ritonavir (400 mg every 12 hours) is contraindicated because ritonavir (400 mg every 12 hours) significantly decreases plasma voriconazole concentrations. Coadministration of voriconazole and low-dose ritonavir (100 mg every 12 hours) should be avoided, unless an assessment of the benefit/risk to the patient justifies the use of voriconazole
[see
Drug Interactions (7)and
Clinical Pharmacology (12.3)]
.
Coadministration of voriconazole tablets with rifabutin is contraindicated since voriconazole tablets significantly increase rifabutin plasma concentrations and rifabutin also significantly decreases voriconazole plasma concentrations
[see
Drug Interactions (7)and
Clinical Pharmacology (12.3)]
.
Coadministration of voriconazole tablets with ergot alkaloids (ergotamine and dihydroergotamine) is contraindicated because voriconazole tablets may increase the plasma concentration of ergot alkaloids, which may lead to ergotism
[see
Drug Interactions (7)]
.
Coadministration of voriconazole tablets with naloxegol is contraindicated because voriconazole tablets may increase plasma concentrations of naloxegol which may precipitate opioid withdrawal symptoms
[see
Drug Interactions (7)]
.
Coadministration of voriconazole tablets with tolvaptan is contraindicated because voriconazole tablets may increase tolvaptan plasma concentrations and increase risk of adverse reactions
[see
Drug Interactions (7)]
.
Coadministration of voriconazole tablets with venetoclax at initiation and during the ramp-up phase is contraindicated in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) due to the potential for increased risk of tumor lysis syndrome
[see
Drug Interactions (7)]
.
Coadministration of voriconazole tablets with lurasidone is contraindicated since it may result in significant increases in lurasidone exposure and the potential for serious adverse reactions
[see
Drug Interactions (7)]
.
Coadministration of voriconazole tablets with finerenone is contraindicated since it may result in significant increases in finerenone exposure and the potential for serious adverse reactions
[seeDrug Interactions (7)]
.
Regulatory & Marketing
Labeler Name
Safecor Health Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA090547
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-06-2026
Listing Expiration
12-31-2027
Hierarchy Structure
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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