Tirofiban Hydrochloride Injection
NDC Package 82169-025-50

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.

Tirofiban Hydrochloride injection is a bulk ingredient utilized for pharmaceutical compounding or manufacturing. This formulation utilizes a injection delivery system. Marketed by Amdipharm Limited, this product is identified by NDC 82169-025.

Identification & Billing

NDC Package Code
82169-025-50
Package Description
48 VIAL, GLASS in 1 CASE / 50 mL in 1 VIAL, GLASS
Product Code
82169-025
11-Digit Billing Format
82169002550

Clinical Specifications

Proprietary Name
Tirofiban Hydrochloride
Non-Proprietary Name
Tirofiban Hydrochloride
Substance Name
Tirofiban Hydrochloride
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Active Ingredient(s)
TIROFIBAN HYDROCHLORIDE .25 mg/mL

Regulatory & Marketing

Labeler Name
Amdipharm Limited
Product Type
Bulk Ingredient
Marketing Category
EXPORT ONLY - A product that is only exported and not marketed in the United States.
Start Marketing Date
01-01-2022
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 82169-025-50 identifies a specific commercial package of 48 vial, glass in 1 case / 50 ml in 1 vial, glass of Tirofiban Hydrochloride (UNFINISHED drug), a bulk ingredient labeled by Amdipharm Limited. This injection is formulated for use and contains tirofiban hydrochloride 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 Amdipharm Limited on January 01, 2022. The current certification is valid through December 31, 2026.

How is this Amdipharm Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82169002550. 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)
82169-025-50
11-Digit CMS (5-4-2)
82169-0025-50

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