Voriconazole Injection, Powder, Lyophilized, For Solution
NDC Package 0781-3416-94

11-digit billing NDC: 00781341694 · Billing unit: EA · 1 EA per package
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Voriconazole injection is •Voriconazole is contraindicated in patients with known hypersensitivity to voriconazole or its excipients [see Warnings and Precautions (5.5) and Adverse Reactions (6.1, 6.2)]. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Sandoz Inc, this product is identified by NDC 0781-3416 and is authorized under FDA application ANDA090862.

Identification & Billing

NDC Package Code
0781-3416-94
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-USE
Product Code
0781-3416
11-Digit Billing Format
00781341694
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
RxCUI: 351209 - voriconazole 200 MG Injection

Clinical Specifications

Proprietary Name
Voriconazole
Non-Proprietary Name
Voriconazole
Substance Name
Voriconazole
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
VORICONAZOLE 10 mg/mL
Pharmacologic Class
Usage Information
•Voriconazole is contraindicated in patients with known hypersensitivity to voriconazole or its excipients [see Warnings and Precautions (5.5) and Adverse Reactions (6.1, 6.2)]. There is no information regarding cross-sensitivity between voriconazole and other azole antifungal agents. Refer to the prescribing information for other azole antifungal agents.•Concomittant use of voriconazole with the interacting drugs described and listed below in this section are a guide and not considered a comprehensive list of all possible drugs that may be contraindicated with voriconazole.1.Concomitant use of voriconazole is contraindicated with drugs that are highly dependent on CYP3A4 for metabolism, and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions [see Drug Interactions (7)]:•Eplerenone•Ergot alkaloids (e.g., ergotamine, dihydroergotamine)•Finerenone•Ivabradine•Lurasidone•Naloxegol•Pimozide•Quinidine•Rifabutin [see Clinical Pharmacology (12.3)]•Sirolimus [see Clinical Pharmacology (12.3)]•Tolvaptan•Venetoclax: Coadministration 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)].•Voclosporin2.Concomitant use of voriconazole is contraindicated with drugs and herbal products that induce CYP2C19, CYP2C9, and/or CYP3A4 and for which significantly reduced voriconazole plasma concentrations may be associated with loss of efficacy [see Drug Interactions (7)]:•Carbamazepine•EfavirenzConcomitant use with efavirenz dosages of 400 mg every 24 hours or higher is contraindicated [see Clinical Pharmacology (12.3)].•Long-acting barbiturates•Rifabutin•Rifampin•RitonavirConcomitant use with high-dose ritonavir (400 mg every 12 hours) is contraindicated. Concomitant use with 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 Clinical Pharmacology (12.3)]•St. John’s Wort [see Clinical Pharmacology (12.3)]

Regulatory & Marketing

Labeler Name
Sandoz Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA090862
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-30-2012
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J3465
Source: ASP
Injection, voriconazole
HCPCS Dosage 10 MG
Units / Pkg 20

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 0781-3416-94 identifies a specific commercial package of 1 vial, single-use in 1 carton / 20 ml in 1 vial, single-use of Voriconazole, a human prescription drug labeled by Sandoz Inc. This injection, powder, lyophilized, for solution is formulated for intravenous 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 Sandoz Inc on May 30, 2012. The current certification is valid through December 31, 2027.

How is this Sandoz Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00781341694. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (4-4-2)
0781-3416-94
11-Digit CMS (5-4-2)
00781-3416-94

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