Fluoxetine Capsule
NDC Package 69367-237-01

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

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Fluoxetine (fluoxetine hydrochloride) capsules is 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 and Olanzapine in Combination is indicated for the treatment of:Acute treatment of depressive episodes associated with Bipolar I Disorder.Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode).Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®. This formulation utilizes a capsule delivery system. Marketed by Westminster Pharmaceuticals, Llc, this product is identified by NDC 69367-237 and is authorized under FDA application ANDA204597.

Identification & Billing

NDC Package Code
69367-237-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
69367-237
11-Digit Billing Format
69367023701
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fluoxetine
Non-Proprietary Name
Fluoxetine Hydrochloride
Substance Name
Fluoxetine Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FLUOXETINE HYDROCHLORIDE 40 mg/1
Pharmacologic Class
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 and Olanzapine in Combination is indicated for the treatment of:Acute treatment of depressive episodes associated with Bipolar I Disorder.Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode).Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax® .

Regulatory & Marketing

Labeler Name
Westminster Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA204597
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-25-2019
End Marketing Date
08-01-2026
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 (69367-237). Click a package code to view its specific billing and regulatory data.

69367-237-05
500 CAPSULE 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 69367-237-01 identifies a specific commercial package of 100 capsule in 1 bottle of Fluoxetine, a human prescription drug labeled by Westminster Pharmaceuticals, Llc. This capsule 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 Westminster Pharmaceuticals, Llc on September 25, 2019.

How is this Westminster Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69367023701. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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 (5-3-2)
69367-237-01
11-Digit CMS (5-4-2)
69367-0237-01

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