Tipranavir Capsule, Liquid Filled
NDC Package 11014-0046-1

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 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.

Tipranavir capsules is this drug must be used with other HIV medications to help control HIV infection. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Catalent Pharma Solutions, Llc, this product is identified by NDC 11014-0046.

Identification & Billing

NDC Package Code
11014-0046-1
Package Description
1 BAG in 1 BOX / 5500 CAPSULE, LIQUID FILLED in 1 BAG
Product Code
11014-0046
11-Digit Billing Format
11014004601

Clinical Specifications

Proprietary Name
Tipranavir
Non-Proprietary Name
Tipranavir
Substance Name
Tipranavir
Dosage Form
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Active Ingredient(s)
TIPRANAVIR 250 mg/1
Usage Information
This drug must be 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. Tipranavir belongs to a class of drugs known as protease inhibitors. It must be given with ritonavir, another protease inhibitor, to increase ("boost") the levels of tipranavir. This helps tipranavir work better. Tipranavir 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
Catalent Pharma Solutions, 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
07-01-2005
Listing Expiration
12-31-2027
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 11014-0046-1 identifies a specific commercial package of 1 bag in 1 box / 5500 capsule, liquid filled in 1 bag of Tipranavir (UNFINISHED drug), drug for further processing labeled by Catalent Pharma Solutions, Llc. This capsule, liquid filled is formulated for use and contains tipranavir 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 Catalent Pharma Solutions, Llc on July 01, 2005. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This drug must be 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. Tipranavir belongs to a class of drugs known as protease inhibitors. It must be given with ritonavir, another protease inhibitor, to increase ("boost") the levels of tipranavir. This helps tipranavir work better. Tipranavir 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 Catalent Pharma Solutions, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11014004601. 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)
11014-0046-1
11-Digit CMS (5-4-2)
11014-0046-01

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