Aptivus Capsule, Liquid Filled
NDC Package 0597-0003-02

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Aptivus (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 Boehringer Ingelheim Pharmaceuticals, Inc., this product is identified by NDC 0597-0003 and is authorized under FDA application NDA021814.

Identification & Billing

NDC Package Code
0597-0003-02
Package Description
120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Product Code
0597-0003
11-Digit Billing Format
00597000302
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
120 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Aptivus
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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TIPRANAVIR 250 mg/1
Pharmacologic Class
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
Boehringer Ingelheim Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021814
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-01-2005
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 0597-0003-02 identifies a specific commercial package of 120 capsule, liquid filled in 1 bottle, plastic of Aptivus, a human prescription drug labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. This capsule, liquid filled is formulated for oral 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 Boehringer Ingelheim Pharmaceuticals, Inc. on July 01, 2005. The current certification is valid through December 31, 2026.

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 Boehringer Ingelheim Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00597000302. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 120 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)
0597-0003-02
11-Digit CMS (5-4-2)
00597-0003-02

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