Edurant Ped Tablet, For Suspension
NDC Package 59676-280-90

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

Package Information

Edurant Ped (rilpivirine hydrochloride) tablets is eDURANT®, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35 kg with plasma HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy. This formulation utilizes a tablet, for suspension delivery system. Marketed by Janssen Products, Lp, this product is identified by NDC 59676-280 and is authorized under FDA application NDA219016.

Identification & Billing

NDC Package Code
59676-280-90
Package Description
9 BLISTER PACK in 1 CARTON / 10 TABLET, FOR SUSPENSION in 1 BLISTER PACK (59676-280-01)
Product Code
59676-280
11-Digit Billing Format
59676028090
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
9 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Edurant Ped
Non-Proprietary Name
Rilpivirine Hydrochloride
Substance Name
Rilpivirine Hydrochloride
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)
RILPIVIRINE HYDROCHLORIDE 2.5 mg/1
Pharmacologic Class
Usage Information
EDURANT®, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35 kg with plasma HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy.

Regulatory & Marketing

Labeler Name
Janssen Products, Lp
Product Type
Human Prescription Drug
FDA Application #
NDA219016
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-15-2024
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 59676-280-90 identifies a specific commercial package of 9 blister pack in 1 carton / 10 tablet, for suspension in 1 blister pack (59676-280-01) of Edurant Ped, a human prescription drug labeled by Janssen Products, Lp. This product is billed for "EA" each discreet unit and contains an estimated amount of 9 billable units per package. This tablet, for suspension is formulated for oral use and contains rilpivirine hydrochloride 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 March 15, 2024. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59676028090. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 9 total billable units per package. 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)
59676-280-90
11-Digit CMS (5-4-2)
59676-0280-90

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