NDC Package 46708-273-91 Fluoxetine

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:
46708-273-91
Package Description:
1000 CAPSULE in 1 BOTTLE
Product Code:
Proprietary Name:
Fluoxetine
Non-Proprietary Name:
Fluoxetine
Substance Name:
Fluoxetine Hydrochloride
Usage Information:
Fluoxetine is 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 and Olanzapine in Combination is indicated for the treatment of: ·         Acute treatment of depressive episodes associated with Bipolar I Disorder in adult. Fluoxetine 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 and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbya® .
11-Digit NDC Billing Format:
46708027391
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
  • RxCUI: 310385 - FLUoxetine 20 MG Oral Capsule
  • RxCUI: 310385 - fluoxetine 20 MG Oral Capsule
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Alembic Pharmaceuticals Limited
    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:
    ANDA090223
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-01-2009
    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
    46708-273-3030 CAPSULE in 1 BOTTLE
    46708-273-31100 CAPSULE in 1 BOTTLE
    46708-273-71500 CAPSULE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 46708-273-91?

    The NDC Packaged Code 46708-273-91 is assigned to a package of 1000 capsule in 1 bottle of Fluoxetine, a human prescription drug labeled by Alembic Pharmaceuticals Limited. The product's dosage form is capsule and is administered via oral form.

    Is NDC 46708-273 included in the NDC Directory?

    Yes, Fluoxetine with product code 46708-273 is active and included in the NDC Directory. The product was first marketed by Alembic Pharmaceuticals Limited on July 01, 2009 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 46708-273-91?

    The 11-digit format is 46708027391. 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
    5-3-246708-273-915-4-246708-0273-91