Tirofiban Hydrochloride Injection, Solution
NDC Package 68083-145-01

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

Package Information

Tirofiban Hydrochloride (tirofiban) injection is tirofiban hydrochloride injection is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS). This formulation utilizes a injection, solution delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-145 and is authorized under FDA application ANDA206888.

Identification & Billing

NDC Package Code
68083-145-01
Package Description
1 CONTAINER in 1 CARTON / 250 mL in 1 CONTAINER
Product Code
68083-145
11-Digit Billing Format
68083014501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tirofiban Hydrochloride
Non-Proprietary Name
Tirofiban
Substance Name
Tirofiban Hydrochloride
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
TIROFIBAN HYDROCHLORIDE 12.5 mg/250mL
Pharmacologic Class
Usage Information
Tirofiban hydrochloride injection is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).

Regulatory & Marketing

Labeler Name
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA206888
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-15-2021
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 68083-145-01 identifies a specific commercial package of 1 container in 1 carton / 250 ml in 1 container of Tirofiban Hydrochloride, a human prescription drug labeled by Gland Pharma Limited. This injection, solution is formulated for intravenous 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 Gland Pharma Limited on April 15, 2021. The current certification is valid through December 31, 2026.

How is this Gland Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083014501. 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)
68083-145-01
11-Digit CMS (5-4-2)
68083-0145-01

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