Emtricitabine And Tenofovir Disoproxil Fumarate
NDC Package 53002-1653-2

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Emtricitabine And Tenofovir Disoproxil Fumarate is tablets for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status [see Warnings and Precautions (5.2)]. . Marketed by Rpk Pharmaceuticals, Inc., this product is identified by NDC 53002-1653 and is authorized under FDA application ANDA090513.

Identification & Billing

NDC Package Code
53002-1653-2
Package Description
21 TABLET, FILM COATED in 1 BOTTLE
Product Code
53002-1653
11-Digit Billing Format
53002165302
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
Dosage Form
-
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
Rpk Pharmaceuticals, Inc.
FDA Application #
ANDA090513
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-30-2021
Listing Expiration
12-31-2024
Exclude Flag
I
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (53002-1653). Click a package code to view its specific billing and regulatory data.

53002-1653-1
10 TABLET, FILM COATED in 1 BOTTLE
53002-1653-3
30 TABLET, FILM COATED in 1 BOTTLE
53002-1653-5
5 TABLET, FILM COATED in 1 BOTTLE
53002-1653-6
6 TABLET, FILM COATED in 1 BOTTLE
53002-1653-7
7 TABLET, FILM COATED in 1 BOTTLE
53002-1653-9
3 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 53002-1653-2 identifies a specific commercial package of 21 tablet, film coated in 1 bottle of Emtricitabine And Tenofovir Disoproxil Fumarate, labeled by Rpk Pharmaceuticals, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Rpk Pharmaceuticals, Inc. on March 30, 2021. The current certification is valid through December 31, 2024.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53002165302. 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)
53002-1653-2
11-Digit CMS (5-4-2)
53002-1653-02

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