Fluoxetine Hcl Powder
NDC Package 60592-212-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Fluoxetine Hcl powders is this long-acting form of fluoxetine is used to treat depression in people who have been successfully treated with the form of fluoxetine that is taken daily. This formulation utilizes a powder delivery system. Marketed by Kalchem International Inc, this product is identified by NDC 60592-212.

Identification & Billing

NDC Package Code
60592-212-10
Package Description
1000 g in 1 BOTTLE
Product Code
60592-212
11-Digit Billing Format
60592021210

Clinical Specifications

Proprietary Name
Fluoxetine Hcl
Non-Proprietary Name
Fluoxetine Hcl
Substance Name
Fluoxetine
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
FLUOXETINE 1 g/g
Usage Information
This long-acting form of fluoxetine is used to treat depression in people who have been successfully treated with the form of fluoxetine that is taken daily. Fluoxetine is a selective serotonin reuptake inhibitor (SSRI). SSRIs work by helping to restore the balance of certain natural substances in the brain (neurotransmitters such as serotonin). Fluoxetine may decrease anxiety, improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living.

Regulatory & Marketing

Labeler Name
Kalchem International Inc
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
10-10-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 60592-212-10 identifies a specific commercial package of 1000 g in 1 bottle of Fluoxetine Hcl (UNFINISHED drug), a bulk ingredient labeled by Kalchem International Inc. This powder is formulated for use and contains fluoxetine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Kalchem International Inc on October 10, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This long-acting form of fluoxetine is used to treat depression in people who have been successfully treated with the form of fluoxetine that is taken daily. Fluoxetine is a selective serotonin reuptake inhibitor (SSRI). SSRIs work by helping to restore the balance of certain natural substances in the brain (neurotransmitters such as serotonin). Fluoxetine may decrease anxiety, improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living.

How is this Kalchem International Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60592021210. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
60592-212-10
11-Digit CMS (5-4-2)
60592-0212-10

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.