Biktarvy Tablet
NDC Package 61958-2501-2

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

Package Information

Biktarvy (bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate) tablets is this combination product is used by itself to help control HIV infection. This formulation utilizes a tablet delivery system. Marketed by Gilead Sciences, Inc., this product is identified by NDC 61958-2501 and is authorized under FDA application NDA210251.

Identification & Billing

NDC Package Code
61958-2501-2
Package Description
7 TABLET in 1 BOTTLE, PLASTIC
Product Code
61958-2501
11-Digit Billing Format
61958250102
RxNorm Crosswalk
  • RxCUI: 1999667 - bictegravir 50 MG / emtricitabine 200 MG / tenofovir alafenamide 25 MG Oral Tablet
  • RxCUI: 1999667 - bictegravir 50 MG (as bictegravir sodium 52.5 MG) / emtricitabine 200 MG / tenofovir alafenamide 25 MG (as tenofovir alafenamide fumarate 28 MG) Oral Tablet
  • RxCUI: 1999673 - Biktarvy 50 MG / 200 MG / 25 MG Oral Tablet
  • RxCUI: 1999673 - bictegravir 50 MG / emtricitabine 200 MG / tenofovir alafenamide 25 MG Oral Tablet [Biktarvy]
  • RxCUI: 2584354 - bictegravir 30 MG / emtricitabine 120 MG / tenofovir alafenamide 15 MG Oral Tablet

Clinical Specifications

Proprietary Name
Biktarvy
Non-Proprietary Name
Bictegravir Sodium, Emtricitabine, And Tenofovir Alafenamide Fumarate
Substance Name
Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This combination product is used by itself 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 is a combination of 3 different drugs: bictegravir, emtricitabine, and tenofovir alafenamide. Bictegravir is called an integrase strand transfer inhibitor-INSTI. Emtricitabine is called a nucleoside reverse transcriptase inhibitor, while tenofovir alafenamide is called a nucleotide reverse transcriptase inhibitor. Emtricitabine and tenofovir alafenamide are often called NRTIs. Bictegravir/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.

Regulatory & Marketing

Labeler Name
Gilead Sciences, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA210251
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-07-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (61958-2501). Click a package code to view its specific billing and regulatory data.

61958-2501-1
30 TABLET in 1 BOTTLE, PLASTIC
61958-2501-3
30 TABLET in 1 BLISTER PACK
61958-2501-5
30 TABLET in 1 BLISTER PACK

* 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 61958-2501-2 identifies a specific commercial package of 7 tablet in 1 bottle, plastic of Biktarvy, a human prescription drug labeled by Gilead Sciences, Inc.. This tablet is formulated for oral use and contains bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate 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 Gilead Sciences, Inc. on February 07, 2018. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This combination product is used by itself 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 is a combination of 3 different drugs: bictegravir, emtricitabine, and tenofovir alafenamide. Bictegravir is called an integrase strand transfer inhibitor-INSTI. Emtricitabine is called a nucleoside reverse transcriptase inhibitor, while tenofovir alafenamide is called a nucleotide reverse transcriptase inhibitor. Emtricitabine and tenofovir alafenamide are often called NRTIs. Bictegravir/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.

How is this Gilead Sciences, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61958250102. 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 (5-4-1)
61958-2501-2
11-Digit CMS (5-4-2)
61958-2501-02

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