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  5. NDC Package Code: 53002-1305-0 Fluoxetine

NDC Package 53002-1305-0 Fluoxetine

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
53002-1305-0
Package Description:
100 CAPSULE in 1 BOTTLE
Product Code:
53002-1305
Proprietary Name:
Fluoxetine
Usage Information:
Fluoxetine capsules are 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 capsules and Olanzapine in Combination are indicated for the treatment of:Acute treatment of depressive episodes associated with Bipolar I Disorder.Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.
11-Digit NDC Billing Format:
53002130500
NDC to RxNorm Crosswalk:
Labeler Name:
Rpk Pharmaceuticals, Inc.
Sample Package:
No
FDA Application Number:
ANDA078619
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
01-31-2008
Listing Expiration Date:
12-31-2024
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.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
53002-1305-330 CAPSULE in 1 BOTTLE
53002-1305-660 CAPSULE in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 53002-1305-0?

The NDC Packaged Code 53002-1305-0 is assigned to a package of 100 capsule in 1 bottle of Fluoxetine, labeled by Rpk Pharmaceuticals, Inc.. The product's dosage form is and is administered via form.

Is NDC 53002-1305 included in the NDC Directory?

No, Fluoxetine with product code 53002-1305 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Rpk Pharmaceuticals, Inc. on January 31, 2008 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 11-digit format for NDC 53002-1305-0?

The 11-digit format is 53002130500. 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
5-4-153002-1305-05-4-253002-1305-00