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  5. NDC Package Code: 68083-145-01 Tirofiban Hydrochloride

NDC Package 68083-145-01 Tirofiban Hydrochloride

Tirofiban Injection, Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
68083-145-01
Package Description:
1 CONTAINER in 1 CARTON / 250 mL in 1 CONTAINER
Product Code:
68083-145
Proprietary Name:
Tirofiban Hydrochloride
Non-Proprietary Name:
Tirofiban
Substance Name:
Tirofiban Hydrochloride
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).
11-Digit NDC Billing Format:
68083014501
NDC to RxNorm Crosswalk:
  • RxCUI: 1737471 - tirofiban 12.5 MG in 250 ML Injection
  • RxCUI: 1737471 - 250 ML tirofiban 0.05 MG/ML Injection
  • RxCUI: 1737471 - tirofiban (as hydrochloride) 12.5 MG per 250 ML Injection
  • RxCUI: 1737471 - tirofiban 12.5 MG per 250 ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Gland Pharma Limited
    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(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • TIROFIBAN HYDROCHLORIDE 12.5 mg/250mL
    • Pharmacologic Class(es):
  • Decreased Platelet Aggregation - [PE] (Physiologic Effect)
  • Platelet Aggregation Inhibitor - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA206888
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-15-2021
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 68083-145-01?

    The NDC Packaged Code 68083-145-01 is assigned to a package of 1 container in 1 carton / 250 ml in 1 container of Tirofiban Hydrochloride, a human prescription drug labeled by Gland Pharma Limited. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 68083-145 included in the NDC Directory?

    Yes, Tirofiban Hydrochloride with product code 68083-145 is active and included in the NDC Directory. The product was first marketed by Gland Pharma Limited on April 15, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 68083-145-01?

    The 11-digit format is 68083014501. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-268083-145-015-4-268083-0145-01