Fluoxetine Capsule
NDC Package 82009-101-10

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

Package Information

Fluoxetine (fluoxetine hydrochloride) capsules is 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.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). This formulation utilizes a capsule delivery system. Marketed by Quallent Pharmaceuticals Health Llc, this product is identified by NDC 82009-101 and is authorized under FDA application ANDA078619.

Identification & Billing

NDC Package Code
82009-101-10
Package Description
1000 CAPSULE in 1 BOTTLE
Product Code
82009-101
11-Digit Billing Format
82009010110
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 20 mg/1
Pharmacologic Class
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.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 capsules 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 capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.

Regulatory & Marketing

Labeler Name
Quallent Pharmaceuticals Health Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA078619
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-01-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 82009-101-10 identifies a specific commercial package of 1000 capsule in 1 bottle of Fluoxetine, a human prescription drug labeled by Quallent Pharmaceuticals Health 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 Quallent Pharmaceuticals Health Llc on September 01, 2023. The current certification is valid through December 31, 2026.

How is this Quallent Pharmaceuticals Health Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82009010110. 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)
82009-101-10
11-Digit CMS (5-4-2)
82009-0101-10

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