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  5. NDC Package Code: 51672-5306-2 Fluoxetine Hydrochloride

NDC Package 51672-5306-2 Fluoxetine Hydrochloride

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
51672-5306-2
Package Description:
500 TABLET, FILM COATED in 1 BOTTLE
Product Code:
51672-5306
Proprietary Name:
Fluoxetine Hydrochloride
Non-Proprietary Name:
Fluoxetine Hydrochloride
Substance Name:
Fluoxetine Hydrochloride
Usage Information:
Fluoxetine is indicated for the treatment of:Major Depressive Disorder (MDD). The efficacy of fluoxetine in MDD was established in one 5-week trial, three 6-week trials, and one maintenance study in adults. The efficacy of fluoxetine was also established in two 8- to 9-week trials in pediatric patients 8 to 18 years of age [see Clinical Studies (14.1)].Obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). The efficacy of fluoxetine in OCD was demonstrated in two 13-week trials in adults and one 13-week trial in pediatric patients 7 to 17 years of age [see Clinical Studies (14.2)].Binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa. The efficacy of fluoxetine in Bulimia Nervosa was demonstrated in two 8-week trials and one 16-week trial in adults [see Clinical Studies (14.3)].Panic Disorder, with or without agoraphobia. The efficacy of fluoxetine in Panic Disorder was demonstrated in two 12-week trials in adults [see Clinical Studies (14.4)].
11-Digit NDC Billing Format:
51672530602
NDC to RxNorm Crosswalk:
  • RxCUI: 1190110 - FLUoxetine HCl 60 MG Oral Tablet
  • RxCUI: 1190110 - fluoxetine 60 MG Oral Tablet
  • RxCUI: 1190110 - fluoxetine (as fluoxetine HCl) 60 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Taro Pharmaceuticals U.s.a., Inc.
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • FLUOXETINE HYDROCHLORIDE 60 mg/1
    • Pharmacologic Class(es):
  • Serotonin Reuptake Inhibitor - [EPC] (Established Pharmacologic Class)
  • Serotonin Uptake Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA211477
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-15-2019
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    51672-5306-630 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 51672-5306-2?

    The NDC Packaged Code 51672-5306-2 is assigned to a package of 500 tablet, film coated in 1 bottle of Fluoxetine Hydrochloride, a human prescription drug labeled by Taro Pharmaceuticals U.s.a., Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 51672-5306 included in the NDC Directory?

    Yes, Fluoxetine Hydrochloride with product code 51672-5306 is active and included in the NDC Directory. The product was first marketed by Taro Pharmaceuticals U.s.a., Inc. on February 15, 2019 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 51672-5306-2?

    The 11-digit format is 51672530602. 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
    5-4-151672-5306-25-4-251672-5306-02