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  5. NDC Package Code: 59676-800-99 Symtuza

NDC Package 59676-800-99 Symtuza

Darunavir,Cobicistat,Emtricitabine,And Tenofovir Alafenamide Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
59676-800-99
Package Description:
30 TABLET, FILM COATED in 1 BOTTLE
Product Code:
59676-800
Proprietary Name:
Symtuza
Non-Proprietary Name:
Darunavir, Cobicistat, Emtricitabine, And Tenofovir Alafenamide
Substance Name:
Cobicistat; Darunavir; Emtricitabine; Tenofovir Alafenamide
Usage Information:
This product is used 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. This product contains 4 different medications: darunavir, cobicistat, emtricitabine, and tenofovir alafenamide. Darunavir is known as a protease inhibitor. Cobicistat helps darunavir work better. Emtricitabine is called a nucleoside reverse transcriptase inhibitor, while tenofovir alafenamide is called a nucleotide reverse transcriptase inhibitor; both kinds of drugs are often called NRTIs. Darunavir/cobicistat/emtricitabine/tenofovir alafenamide 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:
59676080099
NDC to RxNorm Crosswalk:
  • RxCUI: 2049671 - darunavir 800 MG / cobicistat 150 MG / emtricitabine 200 MG / tenofovir alafenamide 10 MG Oral Tablet
  • RxCUI: 2049671 - cobicistat 150 MG / darunavir 800 MG / emtricitabine 200 MG / tenofovir alafenamide 10 MG Oral Tablet
  • RxCUI: 2049677 - Symtuza 800 MG / 150 MG / 200 MG / 10 MG Oral Tablet
  • RxCUI: 2049677 - cobicistat 150 MG / darunavir 800 MG / emtricitabine 200 MG / tenofovir alafenamide 10 MG Oral Tablet [Symtuza]
  • RxCUI: 2049677 - Symtuza (cobicistat 150 MG / as darunavir ethanolate 800 MG / emtricitabine 200 MG / as tenofovir alafenamide fumarate 10 MG ) Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Janssen Products Lp
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • COBICISTAT 150 mg/1
  • DARUNAVIR 800 mg/1
  • EMTRICITABINE 200 mg/1
  • TENOFOVIR ALAFENAMIDE 10 mg/1
    • Pharmacologic Class(es):
  • Breast Cancer Resistance Protein Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 2D6 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A Inhibitor - [EPC] (Established Pharmacologic Class)
  • Cytochrome P450 3A Inhibitors - [MoA] (Mechanism of Action)
  • HIV Protease Inhibitors - [MoA] (Mechanism of Action)
  • Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Multidrug and Toxin Extrusion Transporter 1 Inhibitors - [MoA] (Mechanism of Action)
  • Nucleoside Reverse Transcriptase Inhibitors - [MoA] (Mechanism of Action)
  • Nucleosides - [CS]
  • Organic Anion Transporting Polypeptide 1B1 Inhibitors - [MoA] (Mechanism of Action)
  • Organic Anion Transporting Polypeptide 1B3 Inhibitors - [MoA] (Mechanism of Action)
  • P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)
  • Protease Inhibitor - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    Yes
    FDA Application Number:
    NDA210455
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    07-17-2018
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    59676-800-3030 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 59676-800-99?

    The NDC Packaged Code 59676-800-99 is assigned to a package of 30 tablet, film coated in 1 bottle of Symtuza, a human prescription drug labeled by Janssen Products Lp. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 59676-800 included in the NDC Directory?

    Yes, Symtuza with product code 59676-800 is active and included in the NDC Directory. The product was first marketed by Janssen Products Lp on July 17, 2018 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 11-digit format for NDC 59676-800-99?

    The 11-digit format is 59676080099. 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
    5-3-259676-800-995-4-259676-0800-99