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  5. NDC Package Code: 0527-1947-48 Lopinavir-ritonavir

NDC Package 0527-1947-48 Lopinavir-ritonavir

Solution 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:
0527-1947-48
Package Description:
1 BOTTLE, PLASTIC in 1 CARTON / 160 mL in 1 BOTTLE, PLASTIC
Product Code:
0527-1947
Proprietary Name:
Lopinavir-ritonavir
Non-Proprietary Name:
Lopinavir-ritonavir
Substance Name:
Lopinavir; Ritonavir
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. Because this solution contains other ingredients (alcohol and propylene glycol) that may cause side effects, it is not recommended for premature (pre-term) newborns right after birth or full-term newborns younger than 14 days of age, unless your doctor thinks it is right for your baby. Discuss the risks and benefits with your doctor. 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.
11-Digit NDC Billing Format:
00527194748
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Lannett Company, Inc.
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • LOPINAVIR 80 mg/mL
  • RITONAVIR 20 mg/mL
    • 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:
    ANDA207407
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-27-2016
    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 0527-1947-48?

    The NDC Packaged Code 0527-1947-48 is assigned to a package of 1 bottle, plastic in 1 carton / 160 ml in 1 bottle, plastic of Lopinavir-ritonavir, a human prescription drug labeled by Lannett Company, Inc.. The product's dosage form is solution and is administered via oral form.

    Is NDC 0527-1947 included in the NDC Directory?

    Yes, Lopinavir-ritonavir with product code 0527-1947 is active and included in the NDC Directory. The product was first marketed by Lannett Company, Inc. on December 27, 2016 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 0527-1947-48?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0527-1947-48?

    The 11-digit format is 00527194748. 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 4-4-2 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
    4-4-20527-1947-485-4-200527-1947-48