FDA.reportPublic FDA data

TIROFIBAN HYDROCHLORIDE INJECTION

Manufacturer
Amdipharm Limited
Effective date
2022-03-28
Label type
Bulk Ingredient
Version
2
Source
full-release
Hydrated at
2026-06-01 02:50:25

Label at a glance#

ProductTirofiban Hydrochloride
Active ingredientTIROFIBAN HYDROCHLORIDE
Label structure1 sections

Label contents#

Full prescribing information#

PRINCIPAL DISPLAY PANEL - Shipping Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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


tirofibantirofiban

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
TIROFIBAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3502f65-b30c-cd90-0b5d-36be3bd715c1Product name320240507

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82169-025-50Tirofiban Hydrochloride48 in 1 CASEINJECTION482
82169-025-50Tirofiban Hydrochloride50 mL in 1 VIAL, GLASSINJECTION502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82169-025TIROFIBAN HYDROCHLORIDE INJECTION [AMDIPHARM LIMITED]22 package rows20220330_5cd35e38-b820-4309-ab72-b2111c769b4c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82169-02582169-025-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
TIROFIBAN HYDROCHLORIDE6H925F8O5JACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tirofiban HydrochlorideTIROFIBAN HYDROCHLORIDENexus Pharmaceuticals LLC7731e46a-2121-441b-b090-12dcefe240f02025-02-12Warnings, Adverse reactionsName fallback
brand name: Tirofiban Hydrochloride
generic name: TIROFIBAN HYDROCHLORIDE
Tirofiban HydrochlorideTIROFIBAN HYDROCHLORIDESagent Pharmaceuticals13ea7fb8-4b01-4286-9464-26c0b624bc3b2024-11-09Warnings, Adverse reactionsName fallback
brand name: Tirofiban Hydrochloride
generic name: TIROFIBAN HYDROCHLORIDE
Tirofiban hydrochlorideTIROFIBANGland Pharma Limitedfa3ac570-f9f6-474c-a920-bd0cf03045ac2021-05-19Warnings, Adverse reactionsName fallback
brand name: Tirofiban hydrochloride

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.