Emtricitabine And Tenofovir Disoproxil Fumarate Tablet, Film Coated
NDC Package 68071-3695-3

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

Package Information

Emtricitabine And Tenofovir Disoproxil Fumarate tablets is for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status [ see Warnings and Precautions ( 5.2)]. This formulation utilizes a tablet, film coated delivery system. Marketed by Nucare Pharmaceuticals, Inc., this product is identified by NDC 68071-3695 and is authorized under FDA application ANDA203442.

Identification & Billing

NDC Package Code
68071-3695-3
Package Description
3 TABLET, FILM COATED in 1 BOTTLE
Product Code
68071-3695
11-Digit Billing Format
68071369503
RxNorm Crosswalk
  • RxCUI: 476556 - emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet
  • RxCUI: 476556 - emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet

Clinical Specifications

Proprietary Name
Emtricitabine And Tenofovir Disoproxil Fumarate
Non-Proprietary Name
Emtricitabine And Tenofovir Disoproxil Fumarate
Substance Name
Emtricitabine; 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
Emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status [ see Warnings and Precautions ( 5.2)].

Regulatory & Marketing

Labeler Name
Nucare Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA203442
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-09-2022
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 68071-3695-3 identifies a specific commercial package of 3 tablet, film coated in 1 bottle of Emtricitabine And Tenofovir Disoproxil Fumarate, a human prescription drug labeled by Nucare Pharmaceuticals, Inc.. This tablet, film coated is formulated for oral use and contains emtricitabine; 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 Nucare Pharmaceuticals, Inc. on March 09, 2022. The current certification is valid through December 31, 2026.

How is this Nucare Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071369503. 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)
68071-3695-3
11-Digit CMS (5-4-2)
68071-3695-03

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