Fluconazole Powder, For Suspension
NDC Package 59762-5029-1

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

Package Information

Fluconazole powders is fluconazole is used to treat vaginal yeast infections. This formulation utilizes a powder, for suspension delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 59762-5029 and is authorized under FDA application NDA020090.

Identification & Billing

NDC Package Code
59762-5029-1
Package Description
1 BOTTLE in 1 CARTON / 35 mL in 1 BOTTLE
Product Code
59762-5029
11-Digit Billing Format
59762502901
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fluconazole
Non-Proprietary Name
Fluconazole
Substance Name
Fluconazole
Dosage Form
Powder, For Suspension - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle).
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FLUCONAZOLE 10 mg/mL
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
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA020090
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
12-23-1993
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 59762-5029-1 identifies a specific commercial package of 1 bottle in 1 carton / 35 ml in 1 bottle of Fluconazole, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. This powder, for suspension 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 Mylan Pharmaceuticals Inc. on December 23, 1993. The current certification is valid through December 31, 2027.

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 Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59762502901. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (5-4-1)
59762-5029-1
11-Digit CMS (5-4-2)
59762-5029-01

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