Isentress Tablet, Film Coated
NDC Package 71205-777-90

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

Isentress (raltegravir) tablets is raltegravir is used with other HIV medications to help control HIV infection. This formulation utilizes a tablet, film coated delivery system. Marketed by Proficient Rx Lp, this product is identified by NDC 71205-777 and is authorized under FDA application NDA022145.

Identification & Billing

NDC Package Code
71205-777-90
Package Description
90 TABLET, FILM COATED in 1 BOTTLE
Product Code
71205-777
11-Digit Billing Format
71205077790
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Isentress
Non-Proprietary Name
Raltegravir
Substance Name
Raltegravir Potassium
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)
RALTEGRAVIR POTASSIUM 400 mg/1
Pharmacologic Class
Usage Information
Raltegravir is used with other HIV medications 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. Raltegravir is known as an integrase inhibitor. It blocks the virus from growing and infecting more cells. Raltegravir 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
Proficient Rx Lp
Product Type
Human Prescription Drug
FDA Application #
NDA022145
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-12-2007
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 (71205-777). Click a package code to view its specific billing and regulatory data.

71205-777-06
6 TABLET, FILM COATED in 1 BOTTLE
71205-777-14
14 TABLET, FILM COATED in 1 BOTTLE
71205-777-30
30 TABLET, FILM COATED in 1 BOTTLE
71205-777-60
60 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 71205-777-90 identifies a specific commercial package of 90 tablet, film coated in 1 bottle of Isentress, a human prescription drug labeled by Proficient Rx Lp. This tablet, film coated is formulated for oral use and contains raltegravir potassium 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 Proficient Rx Lp on October 12, 2007. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Raltegravir is used with other HIV medications 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. Raltegravir is known as an integrase inhibitor. It blocks the virus from growing and infecting more cells. Raltegravir 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 Proficient Rx Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71205077790. 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)
71205-777-90
11-Digit CMS (5-4-2)
71205-0777-90

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