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  5. NDC Package Code: 82982-056-03 Emtricitabine And Tenofovir Disoproxil Fumarate

NDC Package 82982-056-03 Emtricitabine And Tenofovir Disoproxil Fumarate

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

Table of Contents

    1. Package Information
    2. 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:
82982-056-03
Package Description:
3 TABLET, FILM COATED in 1 BOTTLE
Product Code:
82982-056
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:
82982005603
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:
    Pharmasource Meds, Llc
    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:
    ANDA203442
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-03-2023
    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.

    Frequently Asked Questions

    What is NDC 82982-056-03?

    The NDC Packaged Code 82982-056-03 is assigned to a package of 3 tablet, film coated in 1 bottle of Emtricitabine And Tenofovir Disoproxil Fumarate, a human prescription drug labeled by Pharmasource Meds, Llc. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 82982-056 included in the NDC Directory?

    Yes, Emtricitabine And Tenofovir Disoproxil Fumarate with product code 82982-056 is active and included in the NDC Directory. The product was first marketed by Pharmasource Meds, Llc on March 03, 2023 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 82982-056-03?

    The 11-digit format is 82982005603. 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
    5-3-282982-056-035-4-282982-0056-03