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  5. NDC Package Code: 42385-934-12 Lopinavir And Ritonavir

NDC Package 42385-934-12 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:
42385-934-12
Package Description:
120 TABLET, FILM COATED in 1 BOTTLE
Product Code:
42385-934
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 HIV- 1 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:
42385093412
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
120 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 597730 - lopinavir 200 MG / ritonavir 50 MG Oral Tablet
  • RxCUI: 746645 - lopinavir 100 MG / ritonavir 25 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Laurus Labs 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):
  • LOPINAVIR 200 mg/1
  • RITONAVIR 50 mg/1
    • Pharmacologic Class(es):
  • Breast Cancer Resistance Protein Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 1A2 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 2B6 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C19 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C9 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 2D6 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A Inhibitor - [EPC] (Established Pharmacologic Class)
  • Cytochrome P450 3A Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A4 Inhibitors - [MoA] (Mechanism of Action)
  • HIV Protease Inhibitors - [MoA] (Mechanism of Action)
  • Organic Anion Transporting Polypeptide 1B1 Inhibitors - [MoA] (Mechanism of Action)
  • P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)
  • Protease Inhibitor - [EPC] (Established Pharmacologic Class)
  • UDP Glucuronosyltransferases Inducers - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA213857
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-22-2022
    Listing Expiration Date:
    12-31-2024
    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 42385-934-12?

    The NDC Packaged Code 42385-934-12 is assigned to a package of 120 tablet, film coated in 1 bottle of Lopinavir And Ritonavir, a human prescription drug labeled by Laurus Labs Limited. The product's dosage form is tablet, film coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 120 billable units per package.

    Is NDC 42385-934 included in the NDC Directory?

    Yes, Lopinavir And Ritonavir with product code 42385-934 is active and included in the NDC Directory. The product was first marketed by Laurus Labs Limited on March 22, 2022 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 42385-934-12?

    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 120.

    What is the 11-digit format for NDC 42385-934-12?

    The 11-digit format is 42385093412. 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
    5-3-242385-934-125-4-242385-0934-12