Tenofovir Disoproxil Fumarate Tablet, Film Coated
NDC Package 65862-421-22

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

Tenofovir Disoproxil Fumarate tablets is tenofovir is used with other HIV medications to help control HIV infection. This formulation utilizes a tablet, film coated delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 65862-421 and is authorized under FDA application ANDA090647.

Identification & Billing

NDC Package Code
65862-421-22
Package Description
2000 TABLET, FILM COATED in 1 BAG
Product Code
65862-421
11-Digit Billing Format
65862042122
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: 1243324 - tenofovir disoproxil fumarate 150 MG Oral Tablet
  • RxCUI: 1243324 - tenofovir disoproxil fumarate 150 MG (equivalent to tenofovir disoproxil 123 MG) Oral Tablet
  • RxCUI: 1243328 - tenofovir disoproxil fumarate 200 MG Oral Tablet

Clinical Specifications

Proprietary Name
Tenofovir Disoproxil Fumarate
Non-Proprietary Name
Tenofovir Disoproxil Fumarate
Substance Name
Tenofovir Disoproxil Fumarate
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
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
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA090647
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-26-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
N/A

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 (65862-421). Click a package code to view its specific billing and regulatory data.

65862-421-30
30 TABLET, FILM COATED in 1 BOTTLE

* 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 65862-421-22 identifies a specific commercial package of 2000 tablet, film coated in 1 bag of Tenofovir Disoproxil Fumarate, a human prescription drug labeled by Aurobindo Pharma Limited. This tablet, film coated 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 Aurobindo Pharma Limited on January 26, 2018. 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 Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65862042122. 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 (5-3-2)
65862-421-22
11-Digit CMS (5-4-2)
65862-0421-22

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