Citalopram Hydrobromide Powder
NDC Package 59349-0010-0

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.

Citalopram Hydrobromide powders is citalopram is used to treat depression. This formulation utilizes a powder delivery system. Marketed by Derivados Quimicos, this product is identified by NDC 59349-0010.

Identification & Billing

NDC Package Code
59349-0010-0
Package Description
25 kg in 1 DRUM
Product Code
59349-0010
11-Digit Billing Format
59349001000

Clinical Specifications

Proprietary Name
Citalopram Hydrobromide
Non-Proprietary Name
Citalopram Hydrobromide
Substance Name
Citalopram Hydrobromide
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)
CITALOPRAM HYDROBROMIDE 1 kg/kg
Usage Information
Citalopram is used to treat depression. It may improve your energy level and feelings of well-being. Citalopram is known as a selective serotonin reuptake inhibitor (SSRI). This medication works by helping to restore the balance of a certain natural substance (serotonin) in the brain.

Regulatory & Marketing

Labeler Name
Derivados Quimicos
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
11-07-2018
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 59349-0010-0 identifies a specific commercial package of 25 kg in 1 drum of Citalopram Hydrobromide (UNFINISHED drug), a bulk ingredient labeled by Derivados Quimicos. This powder is formulated for use and contains citalopram hydrobromide 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 Derivados Quimicos on November 07, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Citalopram is used to treat depression. It may improve your energy level and feelings of well-being. Citalopram is known as a selective serotonin reuptake inhibitor (SSRI). This medication works by helping to restore the balance of a certain natural substance (serotonin) in the brain.

How is this Derivados Quimicos product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59349001000. 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 (5-4-1)
59349-0010-0
11-Digit CMS (5-4-2)
59349-0010-00

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