NDC Package 54458-891-16 Escitalopram

View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

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

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:

54458-891-16

Package Description:

30 TABLET, FILM COATED in 1 BOTTLE

Product Code:

54458-891

Proprietary Name:

Escitalopram

Usage Information:

Escitalopram tablets are indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [see Clinical Studies (14.1)].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.

11-Digit NDC Billing Format:

54458089116

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

30 EA

NDC to RxNorm Crosswalk:

RxCUI: 349332 - escitalopram oxalate 10 MG Oral Tablet

RxCUI: 349332 - escitalopram 10 MG Oral Tablet

RxCUI: 349332 - escitalopram (as escitalopram oxalate) 10 MG Oral Tablet

RxCUI: 351250 - escitalopram oxalate 20 MG Oral Tablet

RxCUI: 351250 - escitalopram 20 MG Oral Tablet

Labeler Name:

International Laboratories, Llc

Sample Package:

Start Marketing Date:

09-20-2013

Listing Expiration Date:

12-31-2020

Exclude Flag:

Code Structure:

54458 - International Laboratories, Llc
- 54458-891 - Escitalopram
  - 54458-891-16 - 30 TABLET, FILM COATED in 1 BOTTLE

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.

Frequently Asked Questions

What is NDC 54458-891-16?

The NDC Packaged Code 54458-891-16 is assigned to a package of 30 tablet, film coated in 1 bottle of Escitalopram, labeled by International Laboratories, Llc. The product's dosage form is and is administered via form.

Is NDC 54458-891 included in the NDC Directory?

No, Escitalopram with product code 54458-891 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by International Laboratories, Llc on September 20, 2013 and its listing in the NDC Directory is set to expire on December 31, 2020 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 54458-891-16?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

What is the 11-digit format for NDC 54458-891-16?

The 11-digit format is 54458089116. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	54458-891-16	5-4-2	54458-0891-16

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