Medicine
Tirofiban 5 mg/100 mL injection
Tirofiban 5 mg/100 mL injection is a generic prescription medicine for intravenous use, made by 2 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Do not freeze. Store tirofiban hydrochloride injection at controlled room…
Key facts
- Active ingredient (INN)
- Tirofiban
- Brand
- Sold under the generic name
- Strength
- 5 mg/100 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 pouch of 100 mL, 1 bag of 100 mL
- Manufacturers
- EugiaIndiaNexus Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store tirofiban hydrochloride injection at controlled room temperature, 25°C (77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Protect from light during storage.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- B01AC17 Tirofiban
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 May 2023
- Identifiers
- RxCUI 1737466, 1737471DailyMed set ID d554acff-22e9-4f28-b826-ee1b91daa2df, 7731e46a-2121-441b-b090-12dcefe240f0NDC 55150-429, 14789-101Application ANDA216379, ANDA213947
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 pouch in 1 carton / 1 bag in 1 pouch / 100 mL in 1 bag | 55150-429-01 | EugiaIndia | 1 May 2023 |
| 1 bag in 1 carton / 100 mL in 1 bag | 14789-101-01 | Nexus Pharmaceuticals | 25 September 2023 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 14 May 1998 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Tirofiban 5 mg/100 mL injection.
Other strengths and forms of Tirofiban
Clinical summary
Tirofiban is a platelet aggregation inhibitor indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS). MedsAcross supplies Tirofiban for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about TirofibanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- AGGRASTAT prescribing information (Medicure International) · U.S. National Library of Medicine, DailyMed
Need Tirofiban 5 mg/100 mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.