Fluconazole In Sodium Chloride
NDC Package 70655-002-06

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Fluconazole In Sodium Chloride is injection, USP is indicated for the treatment of:Oropharyngeal and esophageal candidiasis. Marketed by Renaissance Ssa, Llc, this product is identified by NDC 70655-002 and is authorized under FDA application ANDA076766.

Identification & Billing

NDC Package Code
70655-002-06
Package Description
6 BAG in 1 CARTON / 100 mL in 1 BAG
Product Code
70655-002
11-Digit Billing Format
70655000206
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 In Sodium Chloride
Dosage Form
-
Usage Information
Fluconazole in Sodium Chloride Injection, USP is indicated for the treatment of:Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia.Cryptococcal meningitis. Before prescribing Fluconazole in Sodium Chloride Injection, USP for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.Prophylaxis - Fluconazole in Sodium Chloride Injection, USP 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
Renaissance Ssa, Llc
FDA Application #
ANDA076766
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-12-2018
Listing Expiration
12-31-2019
Exclude Flag
I
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1450
Source: PDAC
INJECTION FLUCONAZOLE, 200 MG
HCPCS Dosage 200 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70655-002). Click a package code to view its specific billing and regulatory data.

70655-002-10
10 BAG in 1 CARTON / 100 mL in 1 BAG

* 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 70655-002-06 identifies a specific commercial package of 6 bag in 1 carton / 100 ml in 1 bag of Fluconazole In Sodium Chloride, labeled by Renaissance Ssa, Llc. 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 Renaissance Ssa, Llc on September 12, 2018. The current certification is valid through December 31, 2019.

How is this Renaissance Ssa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70655000206. 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)
70655-002-06
11-Digit CMS (5-4-2)
70655-0002-06

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