Emtricitabine And Tenofovir Disoproxil Fumarate
NDC Package 69238-1549-3

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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 for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status [see Warnings and Precautions (5.2)]. Marketed by Amneal Pharmaceuticals Ny Llc, this product is identified by NDC 69238-1549 and is authorized under FDA application ANDA209721.

Identification & Billing

NDC Package Code
69238-1549-3
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
69238-1549
11-Digit Billing Format
69238154903
RxNorm Crosswalk
  • RxCUI: 1744001 - emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG Oral Tablet
  • RxCUI: 1744001 - emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG (equivalent to tenofovir disoproxil 123 MG) Oral Tablet
  • RxCUI: 1744005 - emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG Oral Tablet
  • RxCUI: 1744005 - emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG (equivalent to tenofovir disoproxil 163 MG) Oral Tablet
  • RxCUI: 1744009 - emtricitabine 167 MG / tenofovir disoproxil fumarate 250 MG Oral Tablet

Clinical Specifications

Proprietary Name
Emtricitabine And Tenofovir Disoproxil Fumarate
Dosage Form
-
Usage Information
Emtricitabine and tenofovir disoproxil fumarate 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
Amneal Pharmaceuticals Ny Llc
FDA Application #
ANDA209721
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-26-2018
Listing Expiration
12-31-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69238-1549-3 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Emtricitabine And Tenofovir Disoproxil Fumarate, labeled by Amneal Pharmaceuticals Ny Llc. 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 Amneal Pharmaceuticals Ny Llc on August 26, 2018. The current certification is valid through December 31, 2023.

How is this Amneal Pharmaceuticals Ny Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69238154903. 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)
69238-1549-3
11-Digit CMS (5-4-2)
69238-1549-03

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