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Medicine

Prasugrel 10 mg tablet

Prasugrel · Oral
Available on requestPrescription onlyUS FDAGeneric name

Prasugrel 10 mg tablet is a generic prescription medicine for oral use, made by 9 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C…

Key facts

Active ingredient (INN)
Prasugrel
Brand
Sold under the generic name
Strength
10 mg
Dosage form
Tablet
Route
Oral
Packs
30 tablets, 3 blister pack, 30 blister pack and 9 more
Manufacturers
Aurobindo PharmaIndiaAccord HealthcareIndiaUnichem LaboratoriesIndiaApotexBryant Ranch PrepackAmerican Health PackagingAmneal PharmaceuticalsGolden State Medical SupplyMylan Pharmaceuticals
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
B01AC22 Prasugrel
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
12 July 2017
Identifiers
RxCUI 855812, 855818DailyMed set ID 406cc201-89b6-43cc-9e14-a59327a5b4d8, 596c923d-db8d-4b96-bf31-52186a38c30d, cd6bf899-06b7-4f52-96c5-ffc94a7288ff +6NDC 65162-002, 65862-830, 16729-273 +7Application ANDA205913, ANDA205888, ANDA205987 +3

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.

PackCodeLabelerMarketed since
30 tablet, film coated in 1 bottle16729-273-10Accord HealthcareIndia16 January 2019
3 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack65862-830-03Aurobindo PharmaIndia16 October 2017
30 tablet, film coated in 1 bottle65862-830-30Aurobindo PharmaIndia16 October 2017
30 tablet, film coated in 1 bottle29300-302-13Unichem LaboratoriesIndia16 October 2023
30 tablet, film coated in 1 bottle60505-4643-3Apotex16 October 2017
30 tablet, film coated in 1 bottle60505-4856-3Apotex15 February 2025
30 tablet, film coated in 1 bottle65162-002-03Amneal Pharmaceuticals22 June 2018
30 tablet, film coated in 1 bottle, plastic0378-5186-93Mylan Pharmaceuticals15 August 2017
30 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack60687-883-21American Health Packaging2 March 2025
30 tablet, film coated in 1 bottle63629-4829-1Bryant Ranch Prepack25 November 2024
90 tablet, film coated in 1 bottle63629-4829-2Bryant Ranch Prepack25 November 2024
30 tablet, film coated in 1 bottle, plastic51407-445-30Golden State Medical Supply20 January 2021

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 10 July 2009Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS 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 Prasugrel 10 mg tablet.

Compare 1

Other strengths and forms of Prasugrel

Clinical summary

Prasugrel is a P2Y12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI). MedsAcross supplies Prasugrel 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 Prasugrel

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Prasugrel 10 mg tablet 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.