Fluconazole
NDC Package 63304-976-05

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Fluconazole is used to treat vaginal yeast infections. Marketed by Ranbaxy Pharmaceuticals Inc., this product is identified by NDC 63304-976 and is authorized under FDA application ANDA076332.

Identification & Billing

NDC Package Code
63304-976-05
Package Description
35 mL in 1 BOTTLE
Product Code
63304-976
11-Digit Billing Format
63304097605
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
35 ML

Clinical Specifications

Proprietary Name
Fluconazole
Dosage Form
-
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
Ranbaxy Pharmaceuticals Inc.
FDA Application #
ANDA076332
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-29-2004
End Marketing Date
04-25-2012
Listing Expiration
04-25-2012
Exclude Flag
D
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 63304-976-05 identifies a specific commercial package of 35 ml in 1 bottle of Fluconazole, labeled by Ranbaxy Pharmaceuticals Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 35 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Ranbaxy Pharmaceuticals Inc. on July 29, 2004. The current certification is valid through April 25, 2012.

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 Ranbaxy Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63304097605. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 35 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)
63304-976-05
11-Digit CMS (5-4-2)
63304-0976-05

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