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  5. NDC Package Code: 71205-776-90 Emtricitabine And Tenofovir Disoproxil Fumarate

NDC Package 71205-776-90 Emtricitabine And Tenofovir Disoproxil Fumarate

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
71205-776-90
Package Description:
90 TABLET, FILM COATED in 1 BOTTLE
Product Code:
71205-776
Proprietary Name:
Emtricitabine And Tenofovir Disoproxil Fumarate
Non-Proprietary Name:
Emtricitabine And Tenofovir Disoproxil Fumarate
Substance Name:
Emtricitabine; Tenofovir Disoproxil Fumarate
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)]. 
11-Digit NDC Billing Format:
71205077690
NDC to RxNorm Crosswalk:
  • RxCUI: 476556 - emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet
  • RxCUI: 476556 - emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (tenofovir disoproxil 245 MG) Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Proficient Rx Lp
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • EMTRICITABINE 200 mg/1
  • TENOFOVIR DISOPROXIL FUMARATE 300 mg/1
    • Pharmacologic Class(es):
  • Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Nucleoside Reverse Transcriptase Inhibitors - [MoA] (Mechanism of Action)
  • Nucleosides - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA090513
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-30-2021
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    71205-776-077 TABLET, FILM COATED in 1 BOTTLE
    71205-776-3030 TABLET, FILM COATED in 1 BOTTLE
    71205-776-6060 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 71205-776-90?

    The NDC Packaged Code 71205-776-90 is assigned to a package of 90 tablet, film coated in 1 bottle of Emtricitabine And Tenofovir Disoproxil Fumarate, a human prescription drug labeled by Proficient Rx Lp. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 71205-776 included in the NDC Directory?

    Yes, Emtricitabine And Tenofovir Disoproxil Fumarate with product code 71205-776 is active and included in the NDC Directory. The product was first marketed by Proficient Rx Lp on March 30, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 71205-776-90?

    The 11-digit format is 71205077690. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-271205-776-905-4-271205-0776-90