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  5. NDC Package Code: 54838-523-40 Fluoxetine

NDC Package 54838-523-40 Fluoxetine

Fluoxetine Hydrochloride Liquid 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:
54838-523-40
Package Description:
120 mL in 1 BOTTLE, PLASTIC
Product Code:
54838-523
Proprietary Name:
Fluoxetine
Non-Proprietary Name:
Fluoxetine Hydrochloride
Substance Name:
Fluoxetine Hydrochloride
Usage Information:
Fluoxetine oral solution, USP is indicated for the treatment of:Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)].
11-Digit NDC Billing Format:
54838052340
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
120 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 310386 - FLUoxetine 20 MG in 5 mL Oral Solution
  • RxCUI: 310386 - fluoxetine 4 MG/ML Oral Solution
  • RxCUI: 310386 - fluoxetine 20 MG per 5 ML Oral Solution
  • RxCUI: 310386 - fluoxetine 4 MG/ML (as fluoxetine HCl) Oral Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Lannett Company, Inc.
    Dosage Form:
    Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • FLUOXETINE HYDROCHLORIDE 20 mg/5mL
    • Pharmacologic Class(es):
  • Serotonin Reuptake Inhibitor - [EPC] (Established Pharmacologic Class)
  • Serotonin Uptake Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA077849
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-27-2009
    Listing Expiration Date:
    12-31-2024
    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 54838-523-40?

    The NDC Packaged Code 54838-523-40 is assigned to a package of 120 ml in 1 bottle, plastic of Fluoxetine, a human prescription drug labeled by Lannett Company, Inc.. The product's dosage form is liquid and is administered via oral form.

    Is NDC 54838-523 included in the NDC Directory?

    Yes, Fluoxetine with product code 54838-523 is active and included in the NDC Directory. The product was first marketed by Lannett Company, Inc. on August 27, 2009 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 54838-523-40?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 120.

    What is the 11-digit format for NDC 54838-523-40?

    The 11-digit format is 54838052340. 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
    5-3-254838-523-405-4-254838-0523-40