NDC Package 63629-1609-3 Fluoxetine

Fluoxetine Hydrochloride Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

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:
63629-1609-3
Package Description:
60 CAPSULE in 1 BOTTLE
Product Code:
Proprietary Name:
Fluoxetine
Non-Proprietary Name:
Fluoxetine Hydrochloride
Substance Name:
Fluoxetine Hydrochloride
Usage Information:
Fluoxetine capsules are 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 capsules and Olanzapine in Combination are indicated for the treatment of:Acute treatment of depressive episodes associated with Bipolar I Disorder.Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.
11-Digit NDC Billing Format:
63629160903
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
60 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 310384 - FLUoxetine 10 MG Oral Capsule
  • RxCUI: 310384 - fluoxetine 10 MG Oral Capsule
  • RxCUI: 310384 - fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bryant Ranch Prepack
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA078619
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-31-2008
    Listing Expiration Date:
    12-31-2025
    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
    63629-1609-130 CAPSULE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 63629-1609-3?

    The NDC Packaged Code 63629-1609-3 is assigned to a package of 60 capsule in 1 bottle of Fluoxetine, a human prescription drug labeled by Bryant Ranch Prepack. The product's dosage form is capsule and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package.

    Is NDC 63629-1609 included in the NDC Directory?

    Yes, Fluoxetine with product code 63629-1609 is active and included in the NDC Directory. The product was first marketed by Bryant Ranch Prepack on January 31, 2008 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 63629-1609-3?

    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 60.

    What is the 11-digit format for NDC 63629-1609-3?

    The 11-digit format is 63629160903. 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 5-4-1 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
    5-4-163629-1609-35-4-263629-1609-03