Active ingredient
Tirofiban
10 finished FDA listings contain Tirofiban as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- TIROFIBAN HYDROCHLORIDE
- Dosage forms
- Injection, Injection, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 5
- Strengths listed
- 12.5 mg/250ml · 3.75 mg/15ml · 5 mg/100ml · 50 ug/ml
- Brand names in FDA listings
- Aggrastat, Tirofiban Hydrochloride
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 73137
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 020912 | MEDICURE | 1998-05-14 | 2 |
| NDA 020913 | MEDICURE | 1998-05-14 | 2 |
| ANDA 206888 | GLAND | 2021-04-08 | 2 |
| ANDA 213947 | NEXUS | 2023-02-07 | 2 |
| ANDA 216379 | EUGIA PHARMA | 2023-05-01 | 2 |
Official labeling on DailyMed
- TIROFIBAN HYDROCHLORIDE INJECTION [NEXUS PHARMACEUTICALS LLC] · version 10 · 2025-02-21
- AGGRASTAT (TIROFIBAN) INJECTION, SOLUTION [MEDICURE INTERNATIONAL INC] · version 3 · 2024-12-26
- AGGRASTAT (TIROFIBAN) INJECTION, SOLUTION [MEDICURE INTERNATIONAL INC] · version 18 · 2024-12-26
- TIROFIBAN HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] · version 1 · 2024-11-18
- TIROFIBAN INJECTION, SOLUTION [EUGIA US LLC] · version 2 · 2023-07-14
- TIROFIBAN HYDROCHLORIDE (TIROFIBAN) INJECTION, SOLUTION [GLAND PHARMA LIMITED] · version 7 · 2021-05-20
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.