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  5. NDC Package Code: 65862-300-35 Fluconazole

NDC Package 65862-300-35 Fluconazole

Powder, For Suspension Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
65862-300-35
Package Description:
1 BOTTLE in 1 CARTON / 35 mL in 1 BOTTLE
Product Code:
65862-300
Proprietary Name:
Fluconazole
Non-Proprietary Name:
Fluconazole
Substance Name:
Fluconazole
Usage Information:
Fluconazole is used to treat vaginal yeast infections. It works by stopping the growth of common types of vaginal yeast (fungus). This medication belongs to a class of drugs called azole antifungals.
11-Digit NDC Billing Format:
65862030035
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 310352 - fluconazole 10 MG in 1 mL Oral Suspension
  • RxCUI: 310352 - fluconazole 10 MG/ML Oral Suspension
  • RxCUI: 310352 - fluconazole 10 MG per 1 ML Oral Suspension
  • RxCUI: 310352 - fluconazole 10 MG per ML Powder for Oral Suspension
  • RxCUI: 310352 - fluconazole 350 MG per 35 ML Powder for Oral Suspension
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Aurobindo Pharma Limited
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • FLUCONAZOLE 40 mg/mL
    • Pharmacologic Class(es):
  • Azole Antifungal - [EPC] (Established Pharmacologic Class)
  • Azoles - [CS]
  • Cytochrome P450 2C19 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C9 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A4 Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA079150
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-18-2009
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 65862-300-35?

    The NDC Packaged Code 65862-300-35 is assigned to a package of 1 bottle in 1 carton / 35 ml in 1 bottle of Fluconazole, a human prescription drug labeled by Aurobindo Pharma Limited. The product's dosage form is powder, for suspension and is administered via oral form.

    Is NDC 65862-300 included in the NDC Directory?

    Yes, Fluconazole with product code 65862-300 is active and included in the NDC Directory. The product was first marketed by Aurobindo Pharma Limited on September 18, 2009 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 65862-300-35?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 65862-300-35?

    The 11-digit format is 65862030035. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-265862-300-355-4-265862-0300-35