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  5. NDC Package Code: 51655-101-52 Fluoxetine Hydrochloride

NDC Package 51655-101-52 Fluoxetine Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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

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:
51655-101-52
Package Description:
30 CAPSULE in 1 BOTTLE, DISPENSING
Product Code:
51655-101
Proprietary Name:
Fluoxetine Hydrochloride
Usage Information:
1.1 Major Depressive DisorderFluoxetine Capsules USP are indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years [see Clinical Studies (14.1)].The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should periodically be re-evaluated [see Dosage and Administration (2.1)].1.2 Obsessive Compulsive DisorderFluoxetine Capsules USP are indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].The effectiveness of fluoxetine capsules USP in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine capsules USP for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.2)].1.3 Bulimia NervosaFluoxetine Capsules USP are indicated for the acute and maintenance treatment of binge-eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].The physician who elects to use fluoxetine capsules USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.3)].1.4 Panic DisorderFluoxetine Capsules USP are indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients [see Clinical Studies (14.4)].The effectiveness of fluoxetine capsules USP in long-term use, i.e., for more than 12 weeks, has not been established in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine capsules USP for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.4)].1.5 Fluoxetine Capsules USP and Olanzapine in Combination: Depressive Episodes Associated With Bipolar I DisorderWhen using fluoxetine capsules USP and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.Fluoxetine Capsules USP and olanzapine in combination is indicated for the acute treatment of depressive episodes associated with Bipolar I Disorder.Fluoxetine Capsules USP monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
11-Digit NDC Billing Format:
51655010152
NDC to RxNorm Crosswalk:
  • RxCUI: 310384 - FLUoxetine 10 MG Oral Capsule
  • RxCUI: 310384 - fluoxetine 10 MG Oral Capsule
  • RxCUI: 310384 - fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule
    • Labeler Name:
    Northwind Pharmaceuticals, Llc
    Sample Package:
    No
    Start Marketing Date:
    11-03-2014
    Listing Expiration Date:
    12-31-2019
    Exclude Flag:
    I
    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 51655-101-52?

    The NDC Packaged Code 51655-101-52 is assigned to a package of 30 capsule in 1 bottle, dispensing of Fluoxetine Hydrochloride, labeled by Northwind Pharmaceuticals, Llc. The product's dosage form is and is administered via form.

    Is NDC 51655-101 included in the NDC Directory?

    No, Fluoxetine Hydrochloride with product code 51655-101 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Northwind Pharmaceuticals, Llc on November 03, 2014 and its listing in the NDC Directory is set to expire on December 31, 2019 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 51655-101-52?

    The 11-digit format is 51655010152. 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
    5-3-251655-101-525-4-251655-0101-52