Prezcobix Ped Tablet, For Suspension
NDC Package 59676-577-30

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

Package Information

Prezcobix Ped (darunavir ethanolate and cobicistat) tablets is pREZCOBIX® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V). This formulation utilizes a tablet, for suspension delivery system. Marketed by Janssen Products, Lp, this product is identified by NDC 59676-577 and is authorized under FDA application NDA220092.

Identification & Billing

NDC Package Code
59676-577-30
Package Description
30 TABLET, FOR SUSPENSION in 1 BOTTLE
Product Code
59676-577
11-Digit Billing Format
59676057730
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Prezcobix Ped
Non-Proprietary Name
Darunavir Ethanolate And Cobicistat
Substance Name
Darunavir Ethanolate; Cobicistat
Dosage Form
Tablet, For Suspension - A tablet that forms a suspension when placed in a liquid (formerly referred to as a ‘dispersible tablet’).
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
PREZCOBIX® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V).

Regulatory & Marketing

Labeler Name
Janssen Products, Lp
Product Type
Human Prescription Drug
FDA Application #
NDA220092
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-27-2026
Listing Expiration
12-31-2027
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 59676-577-30 identifies a specific commercial package of 30 tablet, for suspension in 1 bottle of Prezcobix Ped, a human prescription drug labeled by Janssen Products, Lp. This tablet, for suspension is formulated for oral use and contains darunavir ethanolate; cobicistat 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 February 27, 2026. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59676057730. 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)
59676-577-30
11-Digit CMS (5-4-2)
59676-0577-30

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