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  5. NDC Package Code: 33342-164-09 Lopinavir And Ritonavir

NDC Package 33342-164-09 Lopinavir And Ritonavir

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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:
33342-164-09
Package Description:
60 TABLET, FILM COATED in 1 BOTTLE
Product Code:
33342-164
Proprietary Name:
Lopinavir And Ritonavir
Non-Proprietary Name:
Lopinavir And Ritonavir
Substance Name:
Lopinavir; Ritonavir
Usage Information:
Lopinavir and ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV1 infection in adults and pediatric patients 14 days and older. Limitations of Use:Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir  [see Microbiology (12.4)].
11-Digit NDC Billing Format:
33342016409
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Macleods Pharmaceuticals Limited
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA204739
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
07-25-2024
Listing Expiration Date:
12-31-2025
Exclude Flag:
N
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.

Frequently Asked Questions

What is NDC 33342-164-09?

The NDC Packaged Code 33342-164-09 is assigned to a package of 60 tablet, film coated in 1 bottle of Lopinavir And Ritonavir, a human prescription drug labeled by Macleods Pharmaceuticals Limited. The product's dosage form is tablet, film coated and is administered via oral form.

Is NDC 33342-164 included in the NDC Directory?

Yes, Lopinavir And Ritonavir with product code 33342-164 is active and included in the NDC Directory. The product was first marketed by Macleods Pharmaceuticals Limited on July 25, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 33342-164-09?

The 11-digit format is 33342016409. 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
5-3-233342-164-095-4-233342-0164-09