NDC Package 61958-2501-3 Biktarvy

Bictegravir Sodium,Emtricitabine,And Tenofovir Alafenamide Fumarate Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

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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:

61958-2501-3

Package Description:

30 TABLET in 1 BLISTER PACK

Product Code:

61958-2501

Proprietary Name:

Biktarvy

Non-Proprietary Name:

Bictegravir Sodium, Emtricitabine, And Tenofovir Alafenamide Fumarate

Substance Name:

Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate

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.

11-Digit NDC Billing Format:

61958250103

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

30 EA

NDC to 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

Product Type:

Human Prescription Drug

Labeler Name:

Gilead Sciences, Inc.

Dosage Form:

Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Administration Route(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

BICTEGRAVIR SODIUM 50 mg/1

EMTRICITABINE 200 mg/1

TENOFOVIR ALAFENAMIDE FUMARATE 25 mg/1

Pharmacologic Class(es):

Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor - [EPC] (Established Pharmacologic Class)

Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor - [EPC] (Established Pharmacologic Class)

Nucleoside Reverse Transcriptase Inhibitors - [MoA] (Mechanism of Action)

Nucleosides - [CS]

Sample Package:

FDA Application Number:

NDA210251

Marketing Category:

NDA - A product marketed under an approved New Drug Application.

Start Marketing Date:

02-07-2018

Listing Expiration Date:

12-31-2025

Exclude Flag:

Code Structure:

61958 - Gilead Sciences, Inc.
- 61958-2501 - Biktarvy
  - 61958-2501-3 - 30 TABLET in 1 BLISTER PACK

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 Code	Package Description
61958-2501-1	30 TABLET in 1 BOTTLE, PLASTIC
61958-2501-2	7 TABLET in 1 BOTTLE, PLASTIC

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 61958-2501-3?

The NDC Packaged Code 61958-2501-3 is assigned to a package of 30 tablet in 1 blister pack of Biktarvy, a human prescription drug labeled by Gilead Sciences, Inc.. The product's dosage form is tablet and is administered via oral form.

Is NDC 61958-2501 included in the NDC Directory?

Yes, Biktarvy with product code 61958-2501 is active and included in the NDC Directory. The product was first marketed by Gilead Sciences, Inc. on February 07, 2018 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 NDC billing unit for package 61958-2501-3?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

What is the 11-digit format for NDC 61958-2501-3?

The 11-digit format is 61958250103. 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 5-4-1 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-4-1	61958-2501-3	5-4-2	61958-2501-03

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