Darunavir Ethanolate Tablet, Film Coated
NDC Package 17314-607-00

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Darunavir Ethanolate tablets is a medication used with other HIV medications to help control HIV infection. This formulation utilizes a tablet, film coated delivery system. Marketed by Janssen Ortho Llc, this product is identified by NDC 17314-607.

Identification & Billing

NDC Package Code
17314-607-00
Package Description
8502 TABLET, FILM COATED in 1 DRUM
Product Code
17314-607
11-Digit Billing Format
17314060700

Clinical Specifications

Proprietary Name
Darunavir Ethanolate
Non-Proprietary Name
Darunavir Ethanolate
Substance Name
Darunavir Ethanolate
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.
Active Ingredient(s)
DARUNAVIR ETHANOLATE 600 mg/1
Usage Information
This drug 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. Darunavir belongs to a class of drugs known as protease inhibitors. Darunavir must be given with certain other medications (such as cobicistat, ritonavir) to increase ("boost") the levels of darunavir. This helps darunavir work better. Darunavir 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. This medication is not recommended for use in children younger than 3 years due to the increased risk of serious side effects.

Regulatory & Marketing

Labeler Name
Janssen Ortho Llc
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
03-08-2008
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 17314-607-00 identifies a specific commercial package of 8502 tablet, film coated in 1 drum of Darunavir Ethanolate (UNFINISHED drug), drug for further processing labeled by Janssen Ortho Llc. This tablet, film coated is formulated for use and contains darunavir ethanolate 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 Janssen Ortho Llc on March 08, 2008. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This drug 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. Darunavir belongs to a class of drugs known as protease inhibitors. Darunavir must be given with certain other medications (such as cobicistat, ritonavir) to increase ("boost") the levels of darunavir. This helps darunavir work better. Darunavir 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. This medication is not recommended for use in children younger than 3 years due to the increased risk of serious side effects.

How is this Janssen Ortho Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17314060700. 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)
17314-607-00
11-Digit CMS (5-4-2)
17314-0607-00

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