Tirofiban Hydrochloride Injection
FDA Label NDC 82169-025

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amdipharm Limited for the product Tirofiban Hydrochloride (NDC 82169-025). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding principal display panel - shipping label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Principal Display Panel - Shipping Label

48 UNLABELED 50mL VIALS

MFG DATE: MMM-YYYY

LOT: ??????


PATHEON PRODUCT CODE: 011287


MANUFACTURED FOR:

AMDIPHARM LIMITED


MANUFACTURED BY:

PATHEON MANUFACTURING SERVICES LLC

GREENVILLE, NC 27834 USA


FOR EXPORT ONLY

TIROFIBAN HYDROCHLORIDE INJECTION

250 MCG PER mL

STORE AT 25°C (77°F) WITH EXCURSIONS PERMITTED BETWEEN 15°C - 30°C (59°F - 86°F).

(SEE USP CONTROLLED ROOM TEMPERATURE). DO NOT FREEZE.

PROTECT FROM LIGHT DURING STORAGE.

NOT FOR RETAIL SALE. FOR REPACKING ONLY.

Rx ONLY


LABEL: 529268


Tirofiban (Tirofiban)

Tirofiban (Tirofiban)

* Please review the disclaimer below.