Prezista Suspension
NDC Package 59676-565-01

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

Package Information

Prezista (darunavir) suspension is a medication used with other HIV medications to help control HIV infection. This formulation utilizes a suspension delivery system. Marketed by Janssen Products Lp, this product is identified by NDC 59676-565 and is authorized under FDA application NDA202895.

Identification & Billing

NDC Package Code
59676-565-01
Package Description
1 BOTTLE, GLASS in 1 CARTON / 200 mL in 1 BOTTLE, GLASS
Product Code
59676-565
11-Digit Billing Format
59676056501
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Prezista
Non-Proprietary Name
Darunavir
Substance Name
Darunavir Ethanolate
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DARUNAVIR ETHANOLATE 100 mg/mL
Pharmacologic Class
Usage Information
This drug 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. Darunavir belongs to a class of drugs known as protease inhibitors. Darunavir must be given with certain other medications (such as cobicistat, ritonavir) to increase ("boost") the levels of darunavir. This helps darunavir work better. Darunavir 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. This medication is not recommended for use in children younger than 3 years due to the increased risk of serious side effects.

Regulatory & Marketing

Labeler Name
Janssen Products Lp
Product Type
Human Prescription Drug
FDA Application #
NDA202895
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-16-2011
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 59676-565-01 identifies a specific commercial package of 1 bottle, glass in 1 carton / 200 ml in 1 bottle, glass of Prezista, a human prescription drug labeled by Janssen Products Lp. This suspension is formulated for oral use and contains darunavir ethanolate 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 Janssen Products Lp on December 16, 2011. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This drug 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. Darunavir belongs to a class of drugs known as protease inhibitors. Darunavir must be given with certain other medications (such as cobicistat, ritonavir) to increase ("boost") the levels of darunavir. This helps darunavir work better. Darunavir 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. This medication is not recommended for use in children younger than 3 years due to the increased risk of serious side effects.

How is this Janssen Products Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59676056501. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
59676-565-01
11-Digit CMS (5-4-2)
59676-0565-01

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