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Medicine

Rasagiline 0.5 mg tablet

Rasagiline · Oral
Available on requestPrescription onlyUS FDAGeneric name

Rasagiline 0.5 mg tablet is a generic prescription medicine for oral use, made by 15 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°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…

Key facts

Active ingredient (INN)
Rasagiline
Brand
Sold under the generic name
Strength
0.5 mg
Dosage form
Tablet
Route
Oral
Packs
30 tablets, 500 tablets, 1000 tablets and 20 more
Manufacturers
Micro LabsIndiaTorrent PharmaceuticalsIndiaAscend LaboratoriesIndiaAurobindo PharmaIndiaMacleods PharmaceuticalsIndiaCarnegie PharmaceuticalsSKG PharmaAlvogenChartwell RXFlorida Pharmaceutical Products
Origin register
US FDA, United States
Storage
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
N04BD02 Rasagiline
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
3 January 2017
Identifiers
RxCUI 608328, 636664DailyMed set ID 5c234b28-29e7-4149-9505-e2818a692bca, 42f8d62f-2c57-47bc-92e7-b28111aa8cd1, 7d9eac3f-7441-45cf-a603-ea18c116e2c0 +12NDC 83085-007, 42571-220, 64980-711 +12Application ANDA218163, ANDA207004, ANDA201892 +8

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 in 1 bottle67877-259-30Ascend LaboratoriesIndia30 October 2017
30 tablet in 1 bottle84386-169-30Aurobindo PharmaIndia20 October 2026
30 tablet in 1 bottle33342-308-07Macleods PharmaceuticalsIndia29 June 2024
500 tablet in 1 bottle42571-220-05Micro LabsIndia3 April 2019
1000 tablet in 1 bottle42571-220-10Micro LabsIndia3 April 2019
30 tablet in 1 bottle42571-220-30Micro LabsIndia3 April 2019
500 tablet in 1 container13668-447-05Torrent PharmaceuticalsIndia15 November 2025
30 tablet in 1 container13668-447-30Torrent PharmaceuticalsIndia15 November 2025
90 tablet in 1 container13668-447-90Torrent PharmaceuticalsIndia15 November 2025
30 tablet in 1 bottle, plastic47781-683-30Alvogen1 March 2019
30 tablet in 1 bottle80005-141-08Carnegie Pharmaceuticals15 January 2026
90 tablet in 1 bottle80005-141-10Carnegie Pharmaceuticals15 January 2026
500 tablet in 1 bottle80005-141-14Carnegie Pharmaceuticals15 January 2026
30 tablet in 1 bottle62135-676-30Chartwell RX1 May 2024
30 tablet in 1 bottle71921-407-33Florida Pharmaceutical Products14 April 2026
30 tablet in 1 bottle64980-711-30Rising Pharma Holdings21 July 2025
1000 tablet in 1 bottle83085-007-10SKG Pharma4 April 2025
30 tablet in 1 bottle83085-007-30SKG Pharma4 April 2025
500 tablet in 1 bottle83085-007-50SKG Pharma4 April 2025
30 tablet in 1 bottle0093-3060-56Teva Pharmaceuticals3 January 2017
30 tablet in 1 bottle51407-008-30Golden State Medical Supply6 April 2026
30 tablet in 1 bottle16714-770-01NorthStar RxLLC17 April 2018
50 pouch in 1 box / 1 tablet in 1 pouch70518-4683-0Remedyrepack26 June 2026

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 16 May 2006Drugs@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 Rasagiline 0.5 mg tablet.

Compare 1

Other strengths and forms of Rasagiline

Clinical summary

Rasagiline is a monoamine oxidase inhibitor indicated for the treatment of Parkinson’s disease (PD). It is available as tablets for oral use. MedsAcross supplies Rasagiline 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 Rasagiline

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

Data sources

Need Rasagiline 0.5 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.