Tolsura Capsule, Gelatin Coated
NDC Package 51862-462-60

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Tolsura (itraconazole) capsules is itraconazole is used to treat a variety of fungal infections. This formulation utilizes a capsule, gelatin coated delivery system. Marketed by Mayne Pharma Commercial Llc, this product is identified by NDC 51862-462 and is authorized under FDA application NDA208901.

Identification & Billing

NDC Package Code
51862-462-60
Package Description
60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC
Product Code
51862-462
11-Digit Billing Format
51862046260
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tolsura
Non-Proprietary Name
Itraconazole
Substance Name
Itraconazole
Dosage Form
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ITRACONAZOLE 65 mg/1
Pharmacologic Class
Usage Information
Itraconazole is used to treat a variety of fungal infections. It belongs to a class of drugs known as azole antifungals. It works by stopping the growth of fungi.

Regulatory & Marketing

Labeler Name
Mayne Pharma Commercial Llc
Product Type
Human Prescription Drug
FDA Application #
NDA208901
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-11-2018
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (51862-462). Click a package code to view its specific billing and regulatory data.

51862-462-08
8 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC
51862-462-88
8 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC

* 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 51862-462-60 identifies a specific commercial package of 60 capsule, gelatin coated in 1 bottle, plastic of Tolsura, a human prescription drug labeled by Mayne Pharma Commercial Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This capsule, gelatin coated is formulated for oral use and contains itraconazole 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 Mayne Pharma Commercial Llc on December 11, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Itraconazole is used to treat a variety of fungal infections. It belongs to a class of drugs known as azole antifungals. It works by stopping the growth of fungi.

How is this Mayne Pharma Commercial Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51862046260. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
51862-462-60
11-Digit CMS (5-4-2)
51862-0462-60

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