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Medicine

Everolimus 1 mg tablet

Everolimus · Oral
Available on requestPrescription onlyUS FDAGeneric name

Everolimus 1 mg tablet is a generic prescription medicine for oral use, made by 8 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 between 15°C and…

Key facts

Active ingredient (INN)
Everolimus
Brand
Sold under the generic name
Strength
1 mg
Dosage form
Tablet
Route
Oral
Packs
6 blister pack, 60 tablets, 60 blister pack and 10 more
Manufacturers
Ascend LaboratoriesIndiaBioconIndiaNatco PharmaIndiaAurobindo PharmaIndiaBreckenridge Pharmaceuticali3 PharmaceuticalsHikma PharmaceuticalsPar Health
Origin register
US FDA, United States
Storage
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from light and moisture.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
L01XE10 Everolimus
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
20 May 2021
Identifiers
RxCUI 977427, 977434, 977438 +1DailyMed set ID be5da0fd-8fd4-4f84-a307-f270048d503c, 2693c497-a70b-4d00-b6db-602c872e5bed, 43ef3c29-0e25-4fdd-aea1-06a20af9bbab +4NDC 72319-017, 67877-721, 59651-934 +5Application ANDA219464, ANDA214138, ANDA219533 +4

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
6 blister pack in 1 carton / 10 tablet in 1 blister pack67877-721-31Ascend LaboratoriesIndia27 November 2021
60 tablet in 1 bottle67877-721-60Ascend LaboratoriesIndia27 November 2021
60 tablet in 1 bottle59651-934-60Aurobindo PharmaIndia25 February 2026
60 tablet in 1 bottle70377-112-11BioconIndia2 June 2025
6 blister pack in 1 carton / 10 tablet in 1 blister pack70377-112-21BioconIndia2 June 2025
60 blister pack in 1 carton / 10 tablet in 1 blister pack63850-0107-2Natco PharmaIndia14 October 2025
60 tablet in 1 bottle63850-0107-3Natco PharmaIndia14 October 2025
60 tablet in 1 bottle51991-985-06Breckenridge Pharmaceutical30 October 2025
60 blister pack in 1 carton / 10 tablet in 1 blister pack51991-985-99Breckenridge Pharmaceutical30 October 2025
60 tablet in 1 bottle0054-0604-21Hikma Pharmaceuticals18 November 2021
60 tablet in 1 container72319-017-02i3 Pharmaceuticals7 August 2026
60 blister pack in 1 carton / 10 tablet in 1 blister pack72319-017-60i3 Pharmaceuticals7 August 2026
6 blister pack in 1 carton / 10 tablet in 1 blister pack49884-283-02Par Health26 January 2022

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 30 March 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 Everolimus 1 mg tablet.

Compare 1

Other strengths and forms of Everolimus

Clinical summary

Everolimus is a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole, among other approved uses. MedsAcross supplies Everolimus 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 Everolimus

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

Data sources

Need Everolimus 1 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.