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  5. NDC Package Code: 54458-980-05 Citalopram

NDC Package 54458-980-05 Citalopram

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:
54458-980-05
Package Description:
360 TABLET, FILM COATED in 1 CARTON
Product Code:
54458-980
Proprietary Name:
Citalopram
Usage Information:
Citalopram tablets USP are indicated for the treatment of depression.The efficacy of citalopram in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-lII and DSM-llI-R category of major depressive disorder (see CLINICAL PHARMACOLOGY).A major depressive episode (DSM-lV) 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 in hospitalized depressed patients has not been adequately studied.The efficacy of citalopram 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 for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
11-Digit NDC Billing Format:
54458098005
NDC to RxNorm Crosswalk:
Labeler Name:
International Labs, Inc.
Sample Package:
No
FDA Application Number:
ANDA077038
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
10-15-2010
End Marketing Date:
12-23-2011
Listing Expiration Date:
12-23-2011
Exclude Flag:
D
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
54458-980-1030 TABLET, FILM COATED in 1 BLISTER PACK
54458-980-1630 TABLET, FILM COATED in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 54458-980-05?

The NDC Packaged Code 54458-980-05 is assigned to a package of 360 tablet, film coated in 1 carton of Citalopram, labeled by International Labs, Inc.. The product's dosage form is and is administered via form.

Is NDC 54458-980 included in the NDC Directory?

No, Citalopram with product code 54458-980 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by International Labs, Inc. on October 15, 2010 and its listing in the NDC Directory is set to expire on December 23, 2011 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 54458-980-05?

The 11-digit format is 54458098005. 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
5-3-254458-980-055-4-254458-0980-05