Fluconazole Tablet
NDC Package 65862-059-01

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

Fluconazole tablets is fluconazole is used to treat vaginal yeast infections. This formulation utilizes a tablet delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 65862-059 and is authorized under FDA application ANDA077731.

Identification & Billing

NDC Package Code
65862-059-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
65862-059
11-Digit Billing Format
65862005901
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fluconazole
Non-Proprietary Name
Fluconazole
Substance Name
Fluconazole
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Fluconazole is used to treat vaginal yeast infections. It works by stopping the growth of common types of vaginal yeast (fungus). This medication belongs to a class of drugs called azole antifungals.

Regulatory & Marketing

Labeler Name
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA077731
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-07-2008
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 (65862-059). Click a package code to view its specific billing and regulatory data.

65862-059-05
500 TABLET in 1 BOTTLE
65862-059-30
30 TABLET in 1 BOTTLE
65862-059-45
4500 TABLET in 1 BAG

* 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 65862-059-01 identifies a specific commercial package of 100 tablet in 1 bottle of Fluconazole, a human prescription drug labeled by Aurobindo Pharma Limited. This tablet is formulated for oral use and contains fluconazole 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 Aurobindo Pharma Limited on October 07, 2008. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Fluconazole is used to treat vaginal yeast infections. It works by stopping the growth of common types of vaginal yeast (fungus). This medication belongs to a class of drugs called azole antifungals.

How is this Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65862005901. 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)
65862-059-01
11-Digit CMS (5-4-2)
65862-0059-01

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