tirofiban

Generic: tirofiban

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tirofiban
Generic Name tirofiban
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tirofiban hydrochloride 5 mg/100mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-429
Product ID 55150-429_1751523a-e22e-4faf-bdb1-c850afe2fd36
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216379
Listing Expiration 2026-12-31
Marketing Start 2023-05-01

Pharmacologic Class

Classes
decreased platelet aggregation [pe] platelet aggregation inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150429
Hyphenated Format 55150-429

Supplemental Identifiers

RxCUI
1737466 1737471
UPC
0355150430017 0355150429011
UNII
6H925F8O5J

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tirofiban (source: ndc)
Generic Name tirofiban (source: ndc)
Application Number ANDA216379 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/100mL
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (55150-429-01) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
source: ndc

Packages (1)

55150-429-01 1 POUCH in 1 CARTON (55150-429-01) / 1 BAG in 1 POUCH / 100 mL in 1 BAG

Ingredients (1)

tirofiban hydrochloride (5 mg/100mL)

Linked Drug Pages (1)

Tirofiban ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "1751523a-e22e-4faf-bdb1-c850afe2fd36", "openfda": {"upc": ["0355150430017", "0355150429011"], "unii": ["6H925F8O5J"], "rxcui": ["1737466", "1737471"], "spl_set_id": ["d554acff-22e9-4f28-b826-ee1b91daa2df"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (55150-429-01)  / 1 BAG in 1 POUCH / 100 mL in 1 BAG", "package_ndc": "55150-429-01", "marketing_start_date": "20230501"}], "brand_name": "Tirofiban", "product_id": "55150-429_1751523a-e22e-4faf-bdb1-c850afe2fd36", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Decreased Platelet Aggregation [PE]", "Platelet Aggregation Inhibitor [EPC]"], "product_ndc": "55150-429", "generic_name": "Tirofiban", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tirofiban", "active_ingredients": [{"name": "TIROFIBAN HYDROCHLORIDE", "strength": "5 mg/100mL"}], "application_number": "ANDA216379", "marketing_category": "ANDA", "marketing_start_date": "20230501", "listing_expiration_date": "20261231"}