Isentress
NDC Package 53808-0650-1

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.

Isentress is raltegravir is used with other HIV medications to help control HIV infection. Marketed by State Of Florida Doh Central Pharmacy, this product is identified by NDC 53808-0650 and is authorized under FDA application NDA022145.

Identification & Billing

NDC Package Code
53808-0650-1
Package Description
30 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
53808-0650
11-Digit Billing Format
53808065001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Isentress
Dosage Form
-
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
State Of Florida Doh Central Pharmacy
FDA Application #
NDA022145
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-01-2009
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 53808-0650-1 identifies a specific commercial package of 30 tablet, film coated in 1 blister pack of Isentress, labeled by State Of Florida Doh Central Pharmacy. 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 State Of Florida Doh Central Pharmacy on July 01, 2009. The current certification is valid through December 31, 2018.

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 State Of Florida Doh Central Pharmacy product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53808065001. 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)
53808-0650-1
11-Digit CMS (5-4-2)
53808-0650-01

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