Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate Tablet, Film Coated
NDC Package 42385-929-91

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate tablets is efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg. This formulation utilizes a tablet, film coated delivery system. Marketed by Laurus Labs Limited, this product is identified by NDC 42385-929 and is authorized under FDA application ANDA213038.

Identification & Billing

NDC Package Code
42385-929-91
Package Description
90 TABLET, FILM COATED in 1 BOTTLE
Product Code
42385-929
11-Digit Billing Format
42385092991
RxNorm Crosswalk
  • RxCUI: 2001424 - efavirenz 400 MG / lamiVUDine 300 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet
  • RxCUI: 2001424 - efavirenz 400 MG / lamivudine 300 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet
  • RxCUI: 2001424 - efavirenz 400 MG / 3TC 300 MG / Tenofovir disoproxil fumarate 300 MG Oral Tablet
  • RxCUI: 2001424 - efavirenz 400 MG / lamivudine 300 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet

Clinical Specifications

Proprietary Name
Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate
Non-Proprietary Name
Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate
Substance Name
Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.

Regulatory & Marketing

Labeler Name
Laurus Labs Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA213038
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-14-2020
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (42385-929). Click a package code to view its specific billing and regulatory data.

42385-929-18
180 TABLET, FILM COATED in 1 BOTTLE
42385-929-30
30 TABLET, FILM COATED in 1 BOTTLE
42385-929-31
30 TABLET, FILM COATED in 1 BOTTLE
42385-929-82
180 TABLET, FILM COATED in 1 BOTTLE
42385-929-90
90 TABLET, FILM COATED in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42385-929-91 identifies a specific commercial package of 90 tablet, film coated in 1 bottle of Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate, a human prescription drug labeled by Laurus Labs Limited. This tablet, film coated is formulated for oral use and contains efavirenz; lamivudine; tenofovir disoproxil fumarate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Laurus Labs Limited on May 14, 2020. The current certification is valid through December 31, 2026.

How is this Laurus Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42385092991. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
42385-929-91
11-Digit CMS (5-4-2)
42385-0929-91

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.