Fluoxetine Hydrochloride Tablet, Film Coated
NDC Package 51672-5306-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Fluoxetine Hydrochloride tablets is fluoxetine is indicated for the treatment of:Major Depressive Disorder (MDD). This formulation utilizes a tablet, film coated delivery system. Marketed by Taro Pharmaceuticals U.s.a., Inc., this product is identified by NDC 51672-5306 and is authorized under FDA application ANDA211477.

Identification & Billing

NDC Package Code
51672-5306-2
Package Description
500 TABLET, FILM COATED in 1 BOTTLE
Product Code
51672-5306
11-Digit Billing Format
51672530602
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fluoxetine Hydrochloride
Non-Proprietary Name
Fluoxetine Hydrochloride
Substance Name
Fluoxetine Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FLUOXETINE HYDROCHLORIDE 60 mg/1
Pharmacologic Class
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)].

Regulatory & Marketing

Labeler Name
Taro Pharmaceuticals U.s.a., Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA211477
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-15-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (51672-5306). Click a package code to view its specific billing and regulatory data.

51672-5306-6
30 TABLET, FILM COATED in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 51672-5306-2 identifies a specific commercial package of 500 tablet, film coated in 1 bottle of Fluoxetine Hydrochloride, a human prescription drug labeled by Taro Pharmaceuticals U.s.a., Inc.. This tablet, film coated is formulated for oral use and contains fluoxetine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Taro Pharmaceuticals U.s.a., Inc. on February 15, 2019. The current certification is valid through December 31, 2026.

How is this Taro Pharmaceuticals U.s.a., Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51672530602. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
51672-5306-2
11-Digit CMS (5-4-2)
51672-5306-02

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.