Fluconazole Tablet
NDC Package 67046-2044-3

11-digit billing NDC: 67046204403
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Fluconazole tablets are indicated for the treatment of:Vaginal candidiasis (vaginal yeast infections due to Candida). This formulation utilizes a tablet delivery system. Marketed by Coupler Llc, this product is identified by NDC 67046-2044 and is authorized under FDA application ANDA077253.

Identification & Billing

NDC Package Code
67046-2044-3
Package Description
30 TABLET in 1 BLISTER PACK
Product Code
67046-2044
11-Digit Billing Format
67046204403

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)
FLUCONAZOLE 200 mg/1
Pharmacologic Class
Usage Information
Fluconazole tablets are indicated for the treatment of:Vaginal candidiasis (vaginal yeast infections due to Candida). Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candidaurinary tract infections, peritonitis, and systemic Candidainfections including candidemia, disseminated candidiasis, and pneumonia. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIESsection. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets are 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
Coupler Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA077253
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-26-2026
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 67046-2044-3 identifies a specific commercial package of 30 tablet in 1 blister pack of Fluconazole, a human prescription drug labeled by Coupler Llc. 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 Coupler Llc on October 26, 2026. The current certification is valid through December 31, 2027.

How is this Coupler Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67046204403. 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)
67046-2044-3
11-Digit CMS (5-4-2)
67046-2044-03

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