Citalopram Hydrobromide
NDC Package 17856-0540-2

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Citalopram Hydrobromide is citalopram Oral Solution USP is indicated for the treatment of depression. Marketed by Atlantic Biologicals Corps, this product is identified by NDC 17856-0540 and is authorized under FDA application ANDA077629.

Identification & Billing

NDC Package Code
17856-0540-2
Package Description
10 mL in 1 CUP
Product Code
17856-0540
11-Digit Billing Format
17856054002
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Citalopram Hydrobromide
Dosage Form
-
Usage Information
Citalopram Oral Solution USP is indicated for the treatment of depression. The efficacy of citalopram Oral Solution USP in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM- III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY).A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.The antidepressant action of citalopram Oral Solution USP in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram Oral Solution USP in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram hydrobromide for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Regulatory & Marketing

Labeler Name
Atlantic Biologicals Corps
FDA Application #
ANDA077629
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-14-2006
Listing Expiration
12-31-2018
Exclude Flag
I
Sample Package
No

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 17856-0540-2 identifies a specific commercial package of 10 ml in 1 cup of Citalopram Hydrobromide, labeled by Atlantic Biologicals Corps. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Atlantic Biologicals Corps on June 14, 2006. The current certification is valid through December 31, 2018.

How is this Atlantic Biologicals Corps product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856054002. 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)
17856-0540-2
11-Digit CMS (5-4-2)
17856-0540-02

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