Fluoxetine Tablet, Film Coated
NDC Package 50228-421-01

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

Fluoxetine tablets is fluoxetine is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years [see Clinical Studies (14.1)]. This formulation utilizes a tablet, film coated delivery system. Marketed by Sciegen Pharmaceuticals, Inc, this product is identified by NDC 50228-421 and is authorized under FDA application ANDA210935.

Identification & Billing

NDC Package Code
50228-421-01
Package Description
100 TABLET, FILM COATED in 1 BOTTLE
Product Code
50228-421
11-Digit Billing Format
50228042101
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
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 20 mg/1
Pharmacologic Class
Usage Information
Fluoxetine is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years [see Clinical Studies (14.1)]. The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should periodically be re-evaluated [see Dosage and Administration (2.1)].

Regulatory & Marketing

Labeler Name
Sciegen Pharmaceuticals, Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA210935
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-20-2019
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 (50228-421). Click a package code to view its specific billing and regulatory data.

50228-421-10
1000 TABLET, FILM COATED in 1 BOTTLE
50228-421-30
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 50228-421-01 identifies a specific commercial package of 100 tablet, film coated in 1 bottle of Fluoxetine, a human prescription drug labeled by Sciegen Pharmaceuticals, 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 Sciegen Pharmaceuticals, Inc on March 20, 2019. The current certification is valid through December 31, 2026.

How is this Sciegen Pharmaceuticals, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50228042101. 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)
50228-421-01
11-Digit CMS (5-4-2)
50228-0421-01

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