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  5. NDC Package Code: 59676-280-90 Edurant Ped

NDC Package 59676-280-90 Edurant Ped

Rilpivirine Hydrochloride Tablet, For Suspension 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:
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
Proprietary Name:
Edurant Ped
Non-Proprietary Name:
Rilpivirine Hydrochloride
Substance Name:
Rilpivirine Hydrochloride
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.
11-Digit NDC Billing Format:
59676028090
Product Type:
Human Prescription Drug
Labeler Name:
Janssen Products, Lp
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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • RILPIVIRINE HYDROCHLORIDE 2.5 mg/1
    • Pharmacologic Class(es):
  • Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Non-Nucleoside Analog - [EXT]
  • Non-Nucleoside Reverse Transcriptase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA219016
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-15-2024
    Listing Expiration Date:
    12-31-2025
    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 59676-280-90?

    The NDC Packaged Code 59676-280-90 is assigned to a 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. The product's dosage form is tablet, for suspension and is administered via oral form.

    Is NDC 59676-280 included in the NDC Directory?

    Yes, Edurant Ped with product code 59676-280 is active and included in the NDC Directory. The product was first marketed by Janssen Products, Lp on March 15, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 59676-280-90?

    The 11-digit format is 59676028090. 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
    5-3-259676-280-905-4-259676-0280-90