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  5. NDC Package Code: 50228-420-30 Fluoxetine

NDC Package 50228-420-30 Fluoxetine

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

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:
50228-420-30
Package Description:
30 TABLET, FILM COATED in 1 BOTTLE
Product Code:
50228-420
Proprietary Name:
Fluoxetine
Non-Proprietary Name:
Fluoxetine
Substance Name:
Fluoxetine Hydrochloride
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)].
11-Digit NDC Billing Format:
50228042030
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 248642 - FLUoxetine 20 MG Oral Tablet
  • RxCUI: 248642 - fluoxetine 20 MG Oral Tablet
  • RxCUI: 248642 - fluoxetine 20 MG (as fluoxetine hydrochloride 22.4 MG) Oral Tablet
  • RxCUI: 313990 - FLUoxetine HCl 10 MG Oral Tablet
  • RxCUI: 313990 - fluoxetine 10 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sciegen Pharmaceuticals, Inc
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • FLUOXETINE HYDROCHLORIDE 10 mg/1
    • Pharmacologic Class(es):
  • Serotonin Reuptake Inhibitor - [EPC] (Established Pharmacologic Class)
  • Serotonin Uptake Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA210935
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-20-2019
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    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
    50228-420-01100 TABLET, FILM COATED in 1 BOTTLE
    50228-420-101000 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 50228-420-30?

    The NDC Packaged Code 50228-420-30 is assigned to a package of 30 tablet, film coated in 1 bottle of Fluoxetine, a human prescription drug labeled by Sciegen Pharmaceuticals, Inc. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 50228-420 included in the NDC Directory?

    Yes, Fluoxetine with product code 50228-420 is active and included in the NDC Directory. The product was first marketed by Sciegen Pharmaceuticals, Inc on March 20, 2019 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 NDC billing unit for package 50228-420-30?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

    What is the 11-digit format for NDC 50228-420-30?

    The 11-digit format is 50228042030. 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 5-3-2 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
    5-3-250228-420-305-4-250228-0420-30