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  5. NDC Package Code: 80426-044-01 Fluoxetine

NDC Package 80426-044-01 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:
80426-044-01
Package Description:
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code:
80426-044
Proprietary Name:
Fluoxetine
Non-Proprietary Name:
Fluoxetine
Substance Name:
Fluoxetine Hydrochloride
Usage Information:
When using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax®.
11-Digit NDC Billing Format:
80426004401
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:
    Pel Healthcare Llc
    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:
    ANDA211444
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-13-2023
    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
    80426-044-02100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 80426-044-01?

    The NDC Packaged Code 80426-044-01 is assigned to a package of 30 tablet, film coated in 1 bottle, plastic of Fluoxetine, a human prescription drug labeled by Pel Healthcare Llc. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 80426-044 included in the NDC Directory?

    Yes, Fluoxetine with product code 80426-044 is active and included in the NDC Directory. The product was first marketed by Pel Healthcare Llc on March 13, 2023 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 11-digit format for NDC 80426-044-01?

    The 11-digit format is 80426004401. 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
    5-3-280426-044-015-4-280426-0044-01