Kaletra Tablet, Film Coated
NDC Package 0074-6799-22

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Kaletra (lopinavir and ritonavir) tablets is this combination product contains two medications: lopinavir and ritonavir. This formulation utilizes a tablet, film coated delivery system. Marketed by Abbvie Inc., this product is identified by NDC 0074-6799 and is authorized under FDA application NDA021906.

Identification & Billing

NDC Package Code
0074-6799-22
Package Description
120 TABLET, FILM COATED in 1 BOTTLE
Product Code
0074-6799
11-Digit Billing Format
00074679922
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
120 EA
RxNorm Crosswalk
  • RxCUI: 311369 - lopinavir 80 MG / ritonavir 20 MG in 1 mL Oral Solution
  • RxCUI: 311369 - lopinavir 80 MG/ML / ritonavir 20 MG/ML Oral Solution
  • RxCUI: 311369 - lopinavir 400 MG / ritonavir 100 MG per 5 ML Oral Solution
  • RxCUI: 311369 - lopinavir 80 MG / ritonavir 20 MG per 1 ML Oral Solution
  • RxCUI: 597730 - lopinavir 200 MG / ritonavir 50 MG Oral Tablet

Clinical Specifications

Proprietary Name
Kaletra
Non-Proprietary Name
Lopinavir And Ritonavir
Substance Name
Lopinavir; Ritonavir
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This combination product contains two medications: lopinavir and ritonavir. This product is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Both lopinavir and ritonavir belong to a class of drugs known as HIV protease inhibitors. Ritonavir increases ("boosts") the levels of lopinavir. This helps lopinavir work better. Lopinavir/ritonavir is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

Regulatory & Marketing

Labeler Name
Abbvie Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021906
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-18-2010
Listing Expiration
12-31-2026
Exclude Flag
N
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0074-6799). Click a package code to view its specific billing and regulatory data.

0074-6799-30
120 TABLET, FILM COATED in 1 BOTTLE

* 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 0074-6799-22 identifies a specific commercial package of 120 tablet, film coated in 1 bottle of Kaletra, a human prescription drug labeled by Abbvie Inc.. This tablet, film coated is formulated for oral use and contains lopinavir; ritonavir 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 Abbvie Inc. on June 18, 2010. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This combination product contains two medications: lopinavir and ritonavir. This product is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Both lopinavir and ritonavir belong to a class of drugs known as HIV protease inhibitors. Ritonavir increases ("boosts") the levels of lopinavir. This helps lopinavir work better. Lopinavir/ritonavir is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

How is this Abbvie Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00074679922. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 120 total billable units per package. 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 (4-4-2)
0074-6799-22
11-Digit CMS (5-4-2)
00074-6799-22

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