Fluconazole Powder, For Suspension
NDC Package 72673-091-14

11-digit billing NDC: 72673009114
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Fluconazole powders is fluconazole for oral suspension is indicated for the treatment of: 1.  Oropharyngeal and esophageal candidiasis. This formulation utilizes a powder, for suspension delivery system. Marketed by Zhejiang Poly Pharm. Co., Ltd., this product is identified by NDC 72673-091 and is authorized under FDA application ANDA215738.

Identification & Billing

NDC Package Code
72673-091-14
Package Description
1 BOTTLE in 1 CARTON / 35 mL in 1 BOTTLE
Product Code
72673-091
11-Digit Billing Format
72673009114
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 40 mg/mL
Pharmacologic Class
Usage Information
Fluconazole for oral suspension is indicated for the treatment of: 1.  Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole for oral suspension was also effective for the treatment of Candidaurinary tract infections, peritonitis, and systemic Candidainfections including candidemia, disseminated candidiasis, and pneumonia. 2.  Cryptococcal meningitis. Before prescribing fluconazole for oral suspension for AIDS patients with cryptococcal meningitis, please see  CLINICAL STUDIESsection. Studies comparing fluconazole for oral suspension to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole for oral suspension is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.

Regulatory & Marketing

Labeler Name
Zhejiang Poly Pharm. Co., Ltd.
Product Type
Human Prescription Drug
FDA Application #
ANDA215738
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-01-2025
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 72673-091-14 identifies a specific commercial package of 1 bottle in 1 carton / 35 ml in 1 bottle of Fluconazole, a human prescription drug labeled by Zhejiang Poly Pharm. Co., Ltd.. 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 Zhejiang Poly Pharm. Co., Ltd. on April 01, 2025. The current certification is valid through December 31, 2027.

How is this Zhejiang Poly Pharm. Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72673009114. 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)
72673-091-14
11-Digit CMS (5-4-2)
72673-0091-14

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