Tenofovir Disoproxil Fumarate Tablet, Coated
NDC Package 69076-105-03

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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, coated delivery system. Marketed by Quinn Pharmaceuticals, this product is identified by NDC 69076-105 and is authorized under FDA application ANDA209498.

Identification & Billing

NDC Package Code
69076-105-03
Package Description
30 TABLET, COATED in 1 BOTTLE, PLASTIC
Product Code
69076-105
11-Digit Billing Format
69076010503
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: 349251 - tenofovir disoproxil fumarate 300 MG Oral Tablet
  • RxCUI: 349251 - tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet

Clinical Specifications

Proprietary Name
Tenofovir Disoproxil Fumarate
Non-Proprietary Name
Tenofovir Disoproxil Fumarate
Substance Name
Tenofovir Disoproxil Fumarate
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TENOFOVIR DISOPROXIL FUMARATE 300 mg/1
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
Quinn Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
ANDA209498
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2020
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 69076-105-03 identifies a specific commercial package of 30 tablet, coated in 1 bottle, plastic of Tenofovir Disoproxil Fumarate, a human prescription drug labeled by Quinn Pharmaceuticals. This tablet, 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 Quinn Pharmaceuticals on January 01, 2020. 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 Quinn Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69076010503. 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 (5-3-2)
69076-105-03
11-Digit CMS (5-4-2)
69076-0105-03

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