FDA.reportPublic FDA data

Tirofiban Hydrochloride

Product NDC
14789-102
11-digit product format
147890102
Labeler code
14789
Product ID
14789-102_2dfa5385-2e91-c26a-e063-6394a90a37aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tirofiban Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Nexus Pharmaceuticals LLC
Application
ANDA213947
Marketing category
ANDA
Marketing start
2023-09-25
Substance
TIROFIBAN HYDROCHLORIDE
Active strength
50 ug/mL
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
Tirofiban Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIROFIBAN HYDROCHLORIDE50 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6H925F8O5J
Rxcui1737466, 1737471

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
14789-102-02Tirofiban Hydrochloride250 mL in 1 BAGINJECTION25010
14789-102-02Tirofiban Hydrochloride1 in 1 CARTONINJECTION110
14789-102-10Tirofiban Hydrochloride2 in 1 CARTONINJECTION210
14789-102-10Tirofiban Hydrochloride250 mL in 1 BAGINJECTION25010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
14789-102-02ML - Milliliter14789-102588da362-7bc5-4d38-81c1-054b2969039412023-10-16
14789-102-10ML - Milliliter14789-102864a71b4-8220-41bd-8e38-7cf401f7213a12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14789-102TIROFIBAN HYDROCHLORIDE INJECTION [NEXUS PHARMACEUTICALS LLC]10Current NDC, 4 package rows20250221_7731e46a-2121-441b-b090-12dcefe240f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737471tirofiban 12.5 MG in 250 ML InjectionPSN7731e46a-2121-441b-b090-12dcefe240f010
1737466tirofiban 5 MG in 100 ML InjectionPSN7731e46a-2121-441b-b090-12dcefe240f010
1737466100 ML tirofiban 0.05 MG/ML InjectionSCD7731e46a-2121-441b-b090-12dcefe240f010
1737471250 ML tirofiban 0.05 MG/ML InjectionSCD7731e46a-2121-441b-b090-12dcefe240f010
1737471tirofiban (as hydrochloride) 12.5 MG per 250 ML InjectionSY7731e46a-2121-441b-b090-12dcefe240f010
1737466tirofiban (as hydrochloride) 5 MG per 100 ML InjectionSY7731e46a-2121-441b-b090-12dcefe240f010
1737471tirofiban 12.5 MG per 250 ML InjectionSY7731e46a-2121-441b-b090-12dcefe240f010
1737466tirofiban 50 MCG per 1 ML InjectionSY7731e46a-2121-441b-b090-12dcefe240f010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
14789-102-02147890102021 BAG in 1 CARTON (14789-102-02) / 250 mL in 1 BAG1 bag2023-09-25NoNoHistorical
14789-102-10147890102102 BAG in 1 CARTON (14789-102-10) / 250 mL in 1 BAG2 bag2024-02-10NoNoHistorical