Voriconazole Tablet, Film Coated
NDC Package 48433-146-03

11-digit billing NDC: 48433014603 · Billing unit: EA · 30 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

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 48433-146 and is authorized under FDA application ANDA090547.

Identification & Billing

NDC Package Code
48433-146-03
Package Description
30 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-146-01)
Product Code
48433-146
11-Digit Billing Format
48433014603
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

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.
Active Ingredient(s)
VORICONAZOLE 50 mg/1
Pharmacologic Class
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
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 48433-146-03 identifies a specific commercial package of 30 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack (48433-146-01) of Voriconazole, a human prescription drug labeled by Safecor Health Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This tablet, film coated is formulated for oral use and contains voriconazole as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Safecor Health Llc on April 06, 2026. The current certification is valid through December 31, 2027.

How is this Safecor Health Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 48433014603. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
48433-146-03
11-Digit CMS (5-4-2)
48433-0146-03

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.