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Medicine

Cyclosporine 100 mg capsule

Cyclosporine · Oral
Available on requestPrescription onlyUS FDAGeneric name

Cyclosporine 100 mg capsule is a generic prescription medicine for oral use, made by 7 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 and Dispense In the original unit-dose container at controlled room…

Key facts

Active ingredient (INN)
Cyclosporine
Brand
Sold under the generic name
Strength
100 mg
Dosage form
Capsule
Route
Oral
Packs
5 blister pack, 30 blister pack, 30 capsules and 4 more
Manufacturers
Aurobindo PharmaIndiaAvet PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaStrides PharmaIndiaAmerican Health PackagingApotexQilu Pharmaceutical
Origin register
US FDA, United States
Storage
Store and Dispense In the original unit-dose container at controlled room temperature 68°F to 77°F (20°C to 25°C).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
L04AD01 Cyclosporine
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
29 May 2002
Identifiers
RxCUI 241834, 835894, 835925 +2DailyMed set ID c36132b2-3ec7-4c43-a25e-75cbdbe3d88d, a8e29b54-e4ab-4bb9-ab6c-e4414a3f025b, 64ec430a-e930-145c-e766-13fb49b64644 +4NDC 64380-129, 68084-921, 75907-048 +4Application ANDA216046, ANDA065040, ANDA065044 +2

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
5 blister pack in 1 carton / 6 capsule, liquid filled in 1 blister pack59651-929-65Aurobindo PharmaIndia17 September 2026
5 blister pack in 1 carton / 6 capsule, liquid filled in 1 blister pack23155-839-30Avet PharmaceuticalsIndia30 November 2022
30 blister pack in 1 box / 1 capsule, liquid filled in 1 blister pack75907-048-30Dr. Reddy's LaboratoriesIndia1 July 2024
5 blister pack in 1 carton / 6 capsule, liquid filled in 1 blister pack64380-129-02Strides PharmaIndia16 August 2022
30 capsule, gelatin coated in 1 bottle60505-0134-0Apotex29 May 2002
5 blister pack in 1 carton / 6 capsule, liquid filled in 1 blister pack67184-0585-1Qilu Pharmaceutical15 September 2025
30 blister pack in 1 box, unit-dose / 1 capsule, gelatin coated in 1 blister pack68084-921-25American Health Packaging3 November 2015

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 14 November 1983Drugs@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 Cyclosporine 100 mg capsule.

Compare all 5

Other strengths and forms of Cyclosporine

Clinical summary

Cyclosporine is a calcineurin inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. It is available as capsules, ophthalmic emulsion and eye drops for oral and topical use. MedsAcross supplies Cyclosporine 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 Cyclosporine

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

Data sources

Need Cyclosporine 100 mg capsule 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.