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  5. NDC Package Code: 70518-3838-0 Fluoxetine Hydrochloride

NDC Package 70518-3838-0 Fluoxetine Hydrochloride

Solution 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:
70518-3838-0
Package Description:
10 CUP in 1 BOX / 5 mL in 1 CUP (70518-3838-1)
Product Code:
70518-3838
Proprietary Name:
Fluoxetine Hydrochloride
Non-Proprietary Name:
Fluoxetine Hydrochloride
Substance Name:
Fluoxetine Hydrochloride
Usage Information:
Fluoxetine 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)]. Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.
11-Digit NDC Billing Format:
70518383800
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:
    Remedyrepack Inc.
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    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:
    ANDA216448
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-21-2018
    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 70518-3838-0?

    The NDC Packaged Code 70518-3838-0 is assigned to a package of 10 cup in 1 box / 5 ml in 1 cup (70518-3838-1) of Fluoxetine Hydrochloride, a human prescription drug labeled by Remedyrepack Inc.. The product's dosage form is solution and is administered via oral form.

    Is NDC 70518-3838 included in the NDC Directory?

    Yes, Fluoxetine Hydrochloride with product code 70518-3838 is active and included in the NDC Directory. The product was first marketed by Remedyrepack Inc. on August 21, 2018 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 11-digit format for NDC 70518-3838-0?

    The 11-digit format is 70518383800. 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 5-4-1 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
    5-4-170518-3838-05-4-270518-3838-00