Viread Powder
NDC Package 61958-0403-1

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

Package Information

Viread (tenofovir disoproxil fumarate) powders is tenofovir is used with other HIV medications to help control HIV infection. This formulation utilizes a powder delivery system. Marketed by Gilead Sciences, Inc., this product is identified by NDC 61958-0403 and is authorized under FDA application NDA022577.

Identification & Billing

NDC Package Code
61958-0403-1
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 60 g in 1 BOTTLE, PLASTIC
Product Code
61958-0403
11-Digit Billing Format
61958040301
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
60 GM
RxNorm Crosswalk
  • RxCUI: 1243227 - tenofovir disoproxil fumarate 250 MG Oral Tablet
  • RxCUI: 1243227 - tenofovir disoproxil fumarate 250 MG (equivalent to tenofovir disoproxil 204 MG) Oral Tablet
  • RxCUI: 1243229 - Viread 250 MG Oral Tablet
  • RxCUI: 1243229 - tenofovir disoproxil fumarate 250 MG Oral Tablet [Viread]
  • RxCUI: 1243229 - Viread 250 MG (equivalent to tenofovir disoproxil 204 MG) Oral Tablet

Clinical Specifications

Proprietary Name
Viread
Non-Proprietary Name
Tenofovir Disoproxil Fumarate
Substance Name
Tenofovir Disoproxil Fumarate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TENOFOVIR DISOPROXIL FUMARATE 40 mg/g
Pharmacologic Class
Usage Information
Tenofovir is used with other HIV medications 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. Tenofovir belongs to a class of drugs known as nucleotide reverse transcriptase inhibitors (NRTIs). Tenofovir 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. Tenofovir is also used to treat a certain type of liver infection called chronic hepatitis B infection. It helps to decrease the amount of hepatitis B virus in your body by interfering with virus growth.

Regulatory & Marketing

Labeler Name
Gilead Sciences, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022577
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-18-2012
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 61958-0403-1 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 60 g in 1 bottle, plastic of Viread, a human prescription drug labeled by Gilead Sciences, Inc.. This product is billed per "GM" gram and contains an estimated amount of 60 billable units per package. This powder is formulated for oral use and contains tenofovir disoproxil 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 January 18, 2012. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Tenofovir is used with other HIV medications 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. Tenofovir belongs to a class of drugs known as nucleotide reverse transcriptase inhibitors (NRTIs). Tenofovir 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. Tenofovir is also used to treat a certain type of liver infection called chronic hepatitis B infection. It helps to decrease the amount of hepatitis B virus in your body by interfering with virus growth.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61958040301. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 60 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 (5-4-1)
61958-0403-1
11-Digit CMS (5-4-2)
61958-0403-01

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