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  5. NDC Package Code: 64380-719-04 Emtricitabine And Tenofovir Disoproxil Fumarate

NDC Package 64380-719-04 Emtricitabine And Tenofovir Disoproxil Fumarate

Tablet 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:
64380-719-04
Package Description:
30 TABLET in 1 BOTTLE, PLASTIC
Product Code:
64380-719
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:
64380071904
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:
    Strides Pharma Science Limited
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    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:
    ANDA091055
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-30-2021
    Listing Expiration Date:
    12-31-2025
    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 64380-719-04?

    The NDC Packaged Code 64380-719-04 is assigned to a package of 30 tablet in 1 bottle, plastic of Emtricitabine And Tenofovir Disoproxil Fumarate, a human prescription drug labeled by Strides Pharma Science Limited. The product's dosage form is tablet and is administered via oral form.

    Is NDC 64380-719 included in the NDC Directory?

    Yes, Emtricitabine And Tenofovir Disoproxil Fumarate with product code 64380-719 is active and included in the NDC Directory. The product was first marketed by Strides Pharma Science Limited on March 30, 2021 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 64380-719-04?

    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 64380-719-04?

    The 11-digit format is 64380071904. 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
    5-3-264380-719-045-4-264380-0719-04