Kaletra
NDC Package 11819-342-20

11-digit billing NDC: 11819034220
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.

Kaletra is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.The following points should be considered when initiating therapy with KALETRA:The use of other active agents with KALETRA is associated with a greater likelihood of treatment response [see Clinical Pharmacology (12.4) and Clinical Studies (14)].Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA [see Clinical Pharmacology (12.4)]. Marketed by Hhs/program Support Center/supply Service Center, this product is identified by NDC 11819-342 and is authorized under FDA application NDA021906.

Identification & Billing

NDC Package Code
11819-342-20
Package Description
20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
11819-342
11-Digit Billing Format
11819034220
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Kaletra
Dosage Form
-
Usage Information
KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.The following points should be considered when initiating therapy with KALETRA:The use of other active agents with KALETRA is associated with a greater likelihood of treatment response [see Clinical Pharmacology (12.4) and Clinical Studies (14)].Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA [see Clinical Pharmacology (12.4)]. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to KALETRA [see Clinical Pharmacology (12.4)].Once daily administration of KALETRA is not recommended for any pediatric patients.

Regulatory & Marketing

Labeler Name
Hhs/program Support Center/supply Service Center
FDA Application #
NDA021906
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-18-2010
Listing Expiration
12-31-2017
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 11819-342-20 identifies a specific commercial package of 20 tablet, film coated in 1 bottle, plastic of Kaletra, labeled by Hhs/program Support Center/supply Service Center. 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 Hhs/program Support Center/supply Service Center on June 18, 2010. The current certification is valid through December 31, 2017.

How is this Hhs/program Support Center/supply Service Center product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11819034220. 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)
11819-342-20
11-Digit CMS (5-4-2)
11819-0342-20

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