Fluconazole Powder, For Suspension
NDC Package 57237-149-35

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 Rising Pharma Holdings, Inc., this product is identified by NDC 57237-149 and is authorized under FDA application ANDA079150.

Identification & Billing

NDC Package Code
57237-149-35
Package Description
1 BOTTLE in 1 CARTON / 35 mL in 1 BOTTLE
Product Code
57237-149
11-Digit Billing Format
57237014935
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
Rising Pharma Holdings, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA079150
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-18-2009
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 57237-149-35 identifies a specific commercial package of 1 bottle in 1 carton / 35 ml in 1 bottle of Fluconazole, a human prescription drug labeled by Rising Pharma Holdings, 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 Rising Pharma Holdings, Inc. on September 18, 2009. 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 Rising Pharma Holdings, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57237014935. 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 (5-3-2)
57237-149-35
11-Digit CMS (5-4-2)
57237-0149-35

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