Diflucan Powder, For Suspension
NDC Package 0049-3450-19

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

Package Information

Diflucan (fluconazole) powders is fluconazole is used to prevent and treat a variety of fungal and yeast infections. This formulation utilizes a powder, for suspension delivery system. Marketed by Roerig, this product is identified by NDC 0049-3450 and is authorized under FDA application NDA020090.

Identification & Billing

NDC Package Code
0049-3450-19
Package Description
1 BOTTLE in 1 CARTON / 35 mL in 1 BOTTLE
Product Code
0049-3450
11-Digit Billing Format
00049345019
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Diflucan
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 1400 mg/35mL
Pharmacologic Class
Usage Information
Fluconazole is used to prevent and treat a variety of fungal and yeast infections. It belongs to a class of drugs called azole antifungals. It works by stopping the growth of certain types of fungus.

Regulatory & Marketing

Labeler Name
Roerig
Product Type
Human Prescription Drug
FDA Application #
NDA020090
Marketing Category
NDA - A product marketed under an approved New Drug Application.
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 0049-3450-19 identifies a specific commercial package of 1 bottle in 1 carton / 35 ml in 1 bottle of Diflucan, a human prescription drug labeled by Roerig. 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 Roerig 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 prevent and treat a variety of fungal and yeast infections. It belongs to a class of drugs called azole antifungals. It works by stopping the growth of certain types of fungus.

How is this Roerig product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00049345019. 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 (4-4-2)
0049-3450-19
11-Digit CMS (5-4-2)
00049-3450-19

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