FDA.reportPublic FDA data

AGGRASTAT

Product NDC
25208-901
11-digit product format
252080901
Labeler code
25208
Product ID
25208-901_d7b2e8c6-afd1-4e94-b780-ed2fc439e3f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TIROFIBAN
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Medicure International Inc
Application
NDA020912
Marketing category
NDA
Marketing start
2016-10-15
Substance
TIROFIBAN HYDROCHLORIDE
Active strength
3.75 mg/15mL
Pharmacologic classes
Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AGGRASTAT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIROFIBAN HYDROCHLORIDE3.75 mg/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6H925F8O5J
Rxcui1737466, 1737468, 1737471, 1737472, 1813035, 1813037

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
25208-901-04AGGRASTAT1 in 1 CARTONINJECTION, SOLUTION13
25208-901-04AGGRASTAT15 mL in 1 VIAL, GLASSINJECTION, SOLUTION153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25208-901-04ML - Milliliter25208-9011ee73bb3-92a8-4263-8fea-94682740838412025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25208-901AGGRASTAT (TIROFIBAN) INJECTION, SOLUTION [MEDICURE INTERNATIONAL INC]3Current NDC, 2 package rows20241226_e850111f-e713-41a2-9c65-21c517cf5511.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737472AGGRASTAT 12.5 MG in 250 ML InjectionPSNe850111f-e713-41a2-9c65-21c517cf55113
1813037Aggrastat 3.75 MG in 15 ML InjectionPSNe850111f-e713-41a2-9c65-21c517cf55113
1737468AGGRASTAT 5 MG in 100 ML InjectionPSNe850111f-e713-41a2-9c65-21c517cf55113
1737471tirofiban 12.5 MG in 250 ML InjectionPSNe850111f-e713-41a2-9c65-21c517cf55113
1813035tirofiban 3.75 MG in 15 ML InjectionPSNe850111f-e713-41a2-9c65-21c517cf55113
1737466tirofiban 5 MG in 100 ML InjectionPSNe850111f-e713-41a2-9c65-21c517cf55113
1737468100 ML tirofiban 0.05 MG/ML Injection [Aggrastat]SBDe850111f-e713-41a2-9c65-21c517cf55113
181303715 ML tirofiban 0.25 MG/ML Injection [Aggrastat]SBDe850111f-e713-41a2-9c65-21c517cf55113
1737472250 ML tirofiban 0.05 MG/ML Injection [Aggrastat]SBDe850111f-e713-41a2-9c65-21c517cf55113
1737466100 ML tirofiban 0.05 MG/ML InjectionSCDe850111f-e713-41a2-9c65-21c517cf55113
181303515 ML tirofiban 0.25 MG/ML InjectionSCDe850111f-e713-41a2-9c65-21c517cf55113
1737471250 ML tirofiban 0.05 MG/ML InjectionSCDe850111f-e713-41a2-9c65-21c517cf55113
181303715 ML Aggrastat 0.25 MG/ML InjectionSYe850111f-e713-41a2-9c65-21c517cf55113
1737472Aggrastat 12.5 MG per 250 ML InjectionSYe850111f-e713-41a2-9c65-21c517cf55113
1813037Aggrastat 3.75 MG per 15 ML InjectionSYe850111f-e713-41a2-9c65-21c517cf55113
1737468Aggrastat 5 MG per 100 ML InjectionSYe850111f-e713-41a2-9c65-21c517cf55113
1737468Aggrastat 50 MCG per 1 ML InjectionSYe850111f-e713-41a2-9c65-21c517cf55113
1737471tirofiban (as hydrochloride) 12.5 MG per 250 ML InjectionSYe850111f-e713-41a2-9c65-21c517cf55113
1737466tirofiban (as hydrochloride) 5 MG per 100 ML InjectionSYe850111f-e713-41a2-9c65-21c517cf55113
1737471tirofiban 12.5 MG per 250 ML InjectionSYe850111f-e713-41a2-9c65-21c517cf55113
1813035tirofiban 3.75 MG per 15 ML InjectionSYe850111f-e713-41a2-9c65-21c517cf55113
1737466tirofiban 50 MCG per 1 ML InjectionSYe850111f-e713-41a2-9c65-21c517cf55113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
25208-901-04252080901041 VIAL, GLASS in 1 CARTON (25208-901-04) / 15 mL in 1 VIAL, GLASS2016-10-15NoNoCurrent