NDC Package 65862-354-30 Emtricitabine And Tenofovir Disoproxil Fumarate

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

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:
65862-354-30
Package Description:
30 TABLET, FILM COATED in 1 BOTTLE
Product Code:
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:
65862035430
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
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:
    Aurobindo Pharma Limited
    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.
  • 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
    65862-354-151500 TABLET, FILM COATED in 1 BAG

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65862-354-30?

    The NDC Packaged Code 65862-354-30 is assigned to a package of 30 tablet, film coated in 1 bottle of Emtricitabine And Tenofovir Disoproxil Fumarate, a human prescription drug labeled by Aurobindo Pharma Limited. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 65862-354 included in the NDC Directory?

    Yes, Emtricitabine And Tenofovir Disoproxil Fumarate with product code 65862-354 is active and included in the NDC Directory. The product was first marketed by Aurobindo Pharma Limited 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 NDC billing unit for package 65862-354-30?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

    What is the 11-digit format for NDC 65862-354-30?

    The 11-digit format is 65862035430. 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
    5-3-265862-354-305-4-265862-0354-30