NDC 70655-088-06 Fluconazole In Sodium Chloride

Package Information

The NDC Code 70655-088-06 is assigned to a package of 6 bag in 1 carton > 200 ml in 1 bag of Fluconazole In Sodium Chloride, labeled by Renaissance Ssa, Llc. The product's dosage form is and is administered via form.This product is billed per "ML" milliliter and contains an estimated amount of 1200 billable units per package.

Field Name Field Value
NDC Code 70655-088-06
Package Description 6 BAG in 1 CARTON > 200 mL in 1 BAG
Product Code 70655-088
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Fluconazole In Sodium Chloride
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
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.
11-Digit NDC Billing Format NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
70655008806
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Estimated Billable Units per Package 1200 ML
NDC to RxNorm Crosswalk
  • RxCUI: 1721314 - fluconazole 400 MG in 200 ML Injection
  • RxCUI: 1721314 - 200 ML fluconazole 2 MG/ML Injection
  • RxCUI: 1721314 - fluconazole 400 MG per 200 ML Injection
  • RxCUI: 1721315 - fluconazole 200 MG per 100 ML Injection
  • RxCUI: 1721315 - 100 ML fluconazole 2 MG/ML Injection
  • Labeler Name Renaissance Ssa, Llc
    Sample Package Sample Package?
    This field Indicates whether this package is a sample packaging or not.
    No
    Start Marketing Date What is the Start Marketing Date?
    This is the date that the labeler indicates was the start of its marketing of the drug product.
    09-12-2018
    Listing Expiration Date What is the Listing Expiration Date?
    This is the date when the listing record will expire if not updated or certified by the product labeler.
    12-31-2019
    Exclude Flag What is the NDC Exclude Flag?
    This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
    I
    NDC Code Structure
    This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

    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.

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    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 70655-088-06 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    70655008806J1450Fluconazole200 MG2006212

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    Other Product Packages

    The following packages are also available for Fluconazole In Sodium Chloride with product NDC 70655-088.

    NDC Package CodePackage Description
    70655-088-1010 BAG in 1 CARTON > 200 mL in 1 BAG

    * Please review the disclaimer below.