Fluoxetine Solution
NDC Package 0121-0721-04

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) solution is fluoxetine is indicated for the treatment of:Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1)]. This formulation utilizes a solution delivery system. Marketed by Pai Holdings, Llc Dba Pai Pharma, this product is identified by NDC 0121-0721 and is authorized under FDA application ANDA076015.

Identification & Billing

NDC Package Code
0121-0721-04
Package Description
120 mL in 1 BOTTLE
Product Code
0121-0721
11-Digit Billing Format
00121072104
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
120 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fluoxetine
Non-Proprietary Name
Fluoxetine Hydrochloride
Substance Name
Fluoxetine Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FLUOXETINE HYDROCHLORIDE 20 mg/5mL
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 monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.

Regulatory & Marketing

Labeler Name
Pai Holdings, Llc Dba Pai Pharma
Product Type
Human Prescription Drug
FDA Application #
ANDA076015
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-30-2002
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 0121-0721-04 identifies a specific commercial package of 120 ml in 1 bottle of Fluoxetine, a human prescription drug labeled by Pai Holdings, Llc Dba Pai Pharma. This solution 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 Pai Holdings, Llc Dba Pai Pharma on January 30, 2002. The current certification is valid through December 31, 2026.

How is this Pai Holdings, Llc Dba Pai Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00121072104. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 120 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 (4-4-2)
0121-0721-04
11-Digit CMS (5-4-2)
00121-0721-04

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