Tirofiban Hydrochloride

Product NDC
25021-417
11-digit product format
250210417
Labeler code
25021
Product ID
25021-417_42fc0d8a-6595-491f-aedb-6451129d239d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tirofiban Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA206888
Marketing category
ANDA
Marketing start
2024-11-15
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
Rxcui1737471

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3502f65-b30c-cd90-0b5d-36be3bd715c1Product name320240507
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-417-84Tirofiban Hydrochloride250 mL in 1 BAGINJECTION, SOLUTION2501
25021-417-84Tirofiban Hydrochloride1 in 1 CARTONINJECTION, SOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-417-84ML - Milliliter25021-417a88f9894-c78a-44f3-8f3d-6b6dd24ff85112025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-417TIROFIBAN HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 2 package rows20241116_13ea7fb8-4b01-4286-9464-26c0b624bc3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737471tirofiban 12.5 MG in 250 ML InjectionPSN13ea7fb8-4b01-4286-9464-26c0b624bc3b1
1737471250 ML tirofiban 0.05 MG/ML InjectionSCD13ea7fb8-4b01-4286-9464-26c0b624bc3b1
1737471tirofiban (as hydrochloride) 12.5 MG per 250 ML InjectionSY13ea7fb8-4b01-4286-9464-26c0b624bc3b1
1737471tirofiban 12.5 MG per 250 ML InjectionSY13ea7fb8-4b01-4286-9464-26c0b624bc3b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-417-84250210417841 BAG in 1 CARTON (25021-417-84) / 250 mL in 1 BAG1 bag2024-11-15NoNoHistorical