Stribild
NDC Package 69189-1201-1

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Stribild is a medication used to help control HIV infection. Marketed by Avera Mckennan Hospital, this product is identified by NDC 69189-1201 and is authorized under FDA application NDA203100.

Identification & Billing

NDC Package Code
69189-1201-1
Package Description
1 TABLET, FILM COATED in 1 DOSE PACK
Product Code
69189-1201
11-Digit Billing Format
69189120101
RxNorm Crosswalk
  • RxCUI: 1306292 - elvitegravir 150 MG / cobicistat 150 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet
  • RxCUI: 1306292 - cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet
  • RxCUI: 1306292 - cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet
  • RxCUI: 1306298 - Stribild 150 MG / 150 MG / 200 MG / 300 MG Oral Tablet
  • RxCUI: 1306298 - cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Stribild]

Clinical Specifications

Proprietary Name
Stribild
Dosage Form
-
Usage Information
This product 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. This product contains 4 different medications: elvitegravir, cobicistat, emtricitabine, and tenofovir. Elvitegravir is known as an integrase inhibitor. Cobicistat helps elvitegravir work better. Emtricitabine is called a nucleoside reverse transcriptase inhibitor, while tenofovir is called a nucleotide reverse transcriptase inhibitor; they are often called NRTIs. Elvitegravir/cobicistat/emtricitabine/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
Avera Mckennan Hospital
FDA Application #
NDA203100
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-28-2015
Listing Expiration
12-31-2018
Exclude Flag
I
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 69189-1201-1 identifies a specific commercial package of 1 tablet, film coated in 1 dose pack of Stribild, labeled by Avera Mckennan Hospital. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Avera Mckennan Hospital on October 28, 2015. The current certification is valid through December 31, 2018.

What are the primary indications for this medication?

This product 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. This product contains 4 different medications: elvitegravir, cobicistat, emtricitabine, and tenofovir. Elvitegravir is known as an integrase inhibitor. Cobicistat helps elvitegravir work better. Emtricitabine is called a nucleoside reverse transcriptase inhibitor, while tenofovir is called a nucleotide reverse transcriptase inhibitor; they are often called NRTIs. Elvitegravir/cobicistat/emtricitabine/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 Avera Mckennan Hospital product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69189120101. 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)
69189-1201-1
11-Digit CMS (5-4-2)
69189-1201-01

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