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  5. NDC Package Code: 43598-632-30 Fluoxetine Hydrochloride

NDC Package 43598-632-30 Fluoxetine Hydrochloride

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:
43598-632-30
Package Description:
30 TABLET, FILM COATED in 1 BOTTLE
Product Code:
43598-632
Proprietary Name:
Fluoxetine Hydrochloride
Non-Proprietary Name:
Fluoxetine Hydrochloride
Substance Name:
Fluoxetine Hydrochloride
Usage Information:
Fluoxetine tablets are indicated for the treatment of:   Major Depressive Disorder (MDD). The efficacy of fluoxetine in MDD was established in one 5 week trial, three 6 week trials, and one maintenance study in adults. The efficacy of fluoxetine was also established in two 8 to 9 week trials in pediatric patients 8 to 18 years of age [see Clinical Studies (14.1)].   Obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). The efficacy of fluoxetine in OCD was demonstrated in two 13 week trials in adults and one 13 week trial in pediatric patients 7 to 17 years of age [see Clinical Studies (14.2)].  Binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa. The efficacy of fluoxetine in Bulimia Nervosa was demonstrated in two 8 week trials and one 16 week trial in adults [see Clinical Studies (14.3)].   Panic Disorder, with or without agoraphobia. The efficacy of fluoxetine in Panic Disorder was demonstrated in two 12 week trials in adults [see Clinical Studies (14.4)].
11-Digit NDC Billing Format:
43598063230
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: 1190110 - FLUoxetine HCl 60 MG Oral Tablet
  • RxCUI: 1190110 - fluoxetine 60 MG Oral Tablet
  • RxCUI: 1190110 - fluoxetine (as fluoxetine HCl) 60 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Dr. Reddy's Laboratories 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 60 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:
    ANDA211721
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-28-2019
    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
    43598-632-01100 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 43598-632-30?

    The NDC Packaged Code 43598-632-30 is assigned to a package of 30 tablet, film coated in 1 bottle of Fluoxetine Hydrochloride, a human prescription drug labeled by Dr. Reddy's Laboratories Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 43598-632 included in the NDC Directory?

    Yes, Fluoxetine Hydrochloride with product code 43598-632 is active and included in the NDC Directory. The product was first marketed by Dr. Reddy's Laboratories Inc. on January 28, 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 43598-632-30?

    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 43598-632-30?

    The 11-digit format is 43598063230. 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
    5-3-243598-632-305-4-243598-0632-30