Complera Tablet, Film Coated
NDC Package 61958-1101-1

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

Package Information

Complera (emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate) tablets is this product contains 3 different medications: emtricitabine, rilpivirine, and tenofovir. This formulation utilizes a tablet, film coated delivery system. Marketed by Gilead Sciences, Inc., this product is identified by NDC 61958-1101 and is authorized under FDA application NDA202123.

Identification & Billing

NDC Package Code
61958-1101-1
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
61958-1101
11-Digit Billing Format
61958110101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
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
  • RxCUI: 1147337 - COMPLERA 200 MG / 25 MG / 300 MG Oral Tablet
  • RxCUI: 1147337 - emtricitabine 200 MG / rilpivirine 25 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Complera]

Clinical Specifications

Proprietary Name
Complera
Non-Proprietary Name
Emtricitabine, Rilpivirine Hydrochloride, And Tenofovir Disoproxil Fumarate
Substance Name
Emtricitabine; Rilpivirine Hydrochloride; 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
This product contains 3 different medications: emtricitabine, rilpivirine, and tenofovir. It is used to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Emtricitabine and tenofovir belong to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs). Rilpivirine belongs to a class of drugs known as non-nucleoside reverse transcriptase inhibitors (NNRTIs). Emtricitabine/rilpivirine/tenofovir is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

Regulatory & Marketing

Labeler Name
Gilead Sciences, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA202123
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-10-2011
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 61958-1101-1 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Complera, a human prescription drug labeled by Gilead Sciences, Inc.. This tablet, film coated is formulated for oral use and contains emtricitabine; rilpivirine hydrochloride; 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 Gilead Sciences, Inc. on August 10, 2011. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This product contains 3 different medications: emtricitabine, rilpivirine, and tenofovir. It is used to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Emtricitabine and tenofovir belong to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs). Rilpivirine belongs to a class of drugs known as non-nucleoside reverse transcriptase inhibitors (NNRTIs). Emtricitabine/rilpivirine/tenofovir is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

How is this Gilead Sciences, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61958110101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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 (5-4-1)
61958-1101-1
11-Digit CMS (5-4-2)
61958-1101-01

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