Vemlidy Tablet
NDC Package 61958-2301-1

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

Package Information

Vemlidy (tenofovir alafenamide) tablets is tenofovir alafenamide is used to treat chronic hepatitis B infection, a viral infection of the liver. This formulation utilizes a tablet delivery system. Marketed by Gilead Sciences, Inc., this product is identified by NDC 61958-2301 and is authorized under FDA application NDA208464.

Identification & Billing

NDC Package Code
61958-2301-1
Package Description
30 TABLET in 1 BOTTLE, PLASTIC
Product Code
61958-2301
11-Digit Billing Format
61958230101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 1858261 - tenofovir alafenamide 25 MG Oral Tablet
  • RxCUI: 1858261 - tenofovir alafenamide 25 MG (equiv. to 28 MG tenofovir alafenamide fumarate) Oral Tablet
  • RxCUI: 1858267 - Vemlidy 25 MG Oral Tablet
  • RxCUI: 1858267 - tenofovir alafenamide 25 MG Oral Tablet [Vemlidy]
  • RxCUI: 1858267 - Vemlidy 25 MG (equiv. to 28 MG tenofovir alafenamide fumarate) Oral Tablet

Clinical Specifications

Proprietary Name
Vemlidy
Non-Proprietary Name
Tenofovir Alafenamide
Substance Name
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)
TENOFOVIR ALAFENAMIDE FUMARATE 25 mg/1
Pharmacologic Class
Usage Information
Tenofovir alafenamide is used to treat chronic hepatitis B infection, a viral infection of the liver. It works by stopping or slowing the growth of the virus. Chronic hepatitis infection can lead to serious liver damage (cirrhosis) and liver cancer. It is not known if tenofovir alafenamide can cure hepatitis B or can prevent you from passing the virus to others. Practice "safer sex" (such as the use of latex condoms) to lower the risk of passing the virus to others.

Regulatory & Marketing

Labeler Name
Gilead Sciences, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA208464
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-10-2016
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 61958-2301-1 identifies a specific commercial package of 30 tablet in 1 bottle, plastic of Vemlidy, a human prescription drug labeled by Gilead Sciences, Inc.. This tablet is formulated for oral use and contains 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 November 10, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Tenofovir alafenamide is used to treat chronic hepatitis B infection, a viral infection of the liver. It works by stopping or slowing the growth of the virus. Chronic hepatitis infection can lead to serious liver damage (cirrhosis) and liver cancer. It is not known if tenofovir alafenamide can cure hepatitis B or can prevent you from passing the virus to others. Practice "safer sex" (such as the use of latex condoms) to lower the risk of passing the virus to others.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61958230101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
61958-2301-1
11-Digit CMS (5-4-2)
61958-2301-01

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