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  5. NDC Package Code: 0378-5440-93 Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate

NDC Package 0378-5440-93 Emtricitabine, Rilpivirine, 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:
0378-5440-93
Package Description:
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code:
0378-5440
Proprietary Name:
Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate
Non-Proprietary Name:
Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate
Substance Name:
Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate
Usage Information:
Emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg:•as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy or•to replace a stable antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no treatment failure and no known substitutions associated with resistance to the individual components of emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets [see Microbiology (12.4) and Clinical Studies (14)].Limitations of Use:•More rilpivirine-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥ 50 copies/mL) compared to rilpivirine-treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL [see Clinical Studies (14)].
11-Digit NDC Billing Format:
00378544093
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: 1147334 - emtricitabine 200 MG / rilpivirine HCl 25 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet
  • RxCUI: 1147334 - emtricitabine 200 MG / rilpivirine 25 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet
  • RxCUI: 1147334 - emtricitabine 200 MG / rilpivirine 25 MG (as rilpivirine hydrochloride 27.5 MG) / tenofovir disoproxil fumarate 300 MG (as tenofovir disoproxil 245 MG) Oral Tablet
Product Type:
Human Prescription Drug
Labeler Name:
Mylan Pharmaceuticals Inc.
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):
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA208452
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
05-27-2025
Listing Expiration Date:
12-31-2026
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 0378-5440-93?

The NDC Packaged Code 0378-5440-93 is assigned to a package of 30 tablet, film coated in 1 bottle, plastic of Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is tablet, film coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package.

Is NDC 0378-5440 included in the NDC Directory?

Yes, Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate with product code 0378-5440 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on May 27, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0378-5440-93?

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 0378-5440-93?

The 11-digit format is 00378544093. 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 4-4-2 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
4-4-20378-5440-935-4-200378-5440-93