Isentress Tablet, Chewable
NDC Package 0006-0477-61

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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, chewable delivery system. Marketed by Merck Sharp & Dohme Llc, this product is identified by NDC 0006-0477 and is authorized under FDA application NDA203045.

Identification & Billing

NDC Package Code
0006-0477-61
Package Description
60 TABLET, CHEWABLE in 1 BOTTLE
Product Code
0006-0477
11-Digit Billing Format
00006047761
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Isentress
Non-Proprietary Name
Raltegravir
Substance Name
Raltegravir Potassium
Dosage Form
Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
RALTEGRAVIR POTASSIUM 100 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
Merck Sharp & Dohme Llc
Product Type
Human Prescription Drug
FDA Application #
NDA203045
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-21-2011
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 0006-0477-61 identifies a specific commercial package of 60 tablet, chewable in 1 bottle of Isentress, a human prescription drug labeled by Merck Sharp & Dohme Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This tablet, chewable 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 Merck Sharp & Dohme Llc on December 21, 2011. 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 Merck Sharp & Dohme Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00006047761. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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 (4-4-2)
0006-0477-61
11-Digit CMS (5-4-2)
00006-0477-61

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