Skip to content
MedsAcross

Medicine

Raloxifene 60 mg tablet

Raloxifene · Oral
Available on requestPrescription onlyUS FDAGeneric name

Raloxifene 60 mg tablet is a generic prescription medicine for oral use, made by 16 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 controlled room temperature, 20° to 25°C (68° to 77°F). The USP…

Key facts

Active ingredient (INN)
Raloxifene
Brand
Sold under the generic name
Strength
60 mg
Dosage form
Tablet
Route
Oral
Packs
100 tablets, 3 blister pack, 2000 tablets and 50 more
Manufacturers
Aurobindo PharmaIndiaCadila PharmaceuticalsIndiaCiplaIndiaDr. Reddy's LaboratoriesIndiaAmneal PharmaceuticalsBryant Ranch PrepackExelan PharmaceuticalsModavar PharmaceuticalsScieGen PharmaceuticalsTeva Pharmaceuticals16 labelers on the register
Origin register
US FDA, United States
Storage
Store at controlled room temperature, 20° to 25°C (68° to 77°F). The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F), that results in a mean kinetic temperature calculated to be not more than 25°C, and that allows for excursions between 15° and 30°C (59° and 86°F) that…
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
G03XC01 Raloxifene
HS code (indicative)
3004.39Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
28 March 2014
Identifiers
RxCUI 1490065DailyMed set ID 6fd63a06-5bc5-4c50-9b85-b09c89100b80, 53a2db10-4af8-4032-b598-b7c7a0969801, 3798c70b-a4b0-4811-9788-e4c9cff47ebe +18NDC 71610-053, 71610-524, 65162-057 +18Application ANDA206384, ANDA090842, ANDA208206 +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

A sample of 40 packs from 16 labelers. The register lists 53 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
100 tablet, film coated in 1 bottle65862-709-01Aurobindo PharmaIndia28 August 2015
3 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack65862-709-03Aurobindo PharmaIndia28 August 2015
2000 tablet, film coated in 1 bottle65862-709-22Aurobindo PharmaIndia28 August 2015
30 tablet, film coated in 1 bottle65862-709-30Aurobindo PharmaIndia28 August 2015
1000 tablet, film coated in 1 bottle65862-709-99Aurobindo PharmaIndia28 August 2015
30 tablet, coated in 1 bottle71209-082-01Cadila PharmaceuticalsIndia30 December 2017
100 tablet, coated in 1 bottle71209-082-05Cadila PharmaceuticalsIndia30 December 2017
1000 tablet, coated in 1 bottle71209-082-11Cadila PharmaceuticalsIndia13 December 2021
2000 tablet, coated in 1 bottle71209-082-13Cadila PharmaceuticalsIndia30 December 2017
30 tablet in 1 bottle69097-825-02CiplaIndia29 June 2016
100 tablet in 1 bottle69097-825-07CiplaIndia29 June 2016
1000 tablet in 1 bottle69097-825-15CiplaIndia29 June 2016
100 tablet, film coated in 1 bottle43598-505-01Dr. Reddy's LaboratoriesIndia12 October 2016
1000 tablet, film coated in 1 bottle43598-505-10Dr. Reddy's LaboratoriesIndia12 October 2016
30 tablet, film coated in 1 bottle43598-505-30Dr. Reddy's LaboratoriesIndia12 October 2016
30 tablet, film coated in 1 bottle65162-057-03Amneal Pharmaceuticals20 January 2016
90 tablet, film coated in 1 bottle65162-057-09Amneal Pharmaceuticals20 January 2016
100 tablet, film coated in 1 bottle65162-057-10Amneal Pharmaceuticals20 January 2016
1000 tablet, film coated in 1 bottle65162-057-11Amneal Pharmaceuticals20 January 2016
2000 tablet, film coated in 1 bottle65162-057-33Amneal Pharmaceuticals20 January 2016
500 tablet, film coated in 1 bottle65162-057-50Amneal Pharmaceuticals20 January 2016
100 tablet, film coated in 1 bottle76282-256-01Exelan Pharmaceuticals12 November 2014
500 tablet, film coated in 1 bottle76282-256-05Exelan Pharmaceuticals12 November 2014
1000 tablet, film coated in 1 bottle76282-256-10Exelan Pharmaceuticals15 April 2015
30 tablet, film coated in 1 bottle76282-256-30Exelan Pharmaceuticals12 November 2014
90 tablet, film coated in 1 bottle76282-256-90Exelan Pharmaceuticals15 April 2015
100 tablet, coated in 1 bottle72241-010-05Modavar Pharmaceuticals30 December 2017
1000 tablet, coated in 1 bottle72241-010-11Modavar Pharmaceuticals30 December 2017
2000 tablet, coated in 1 bottle72241-010-13Modavar Pharmaceuticals30 December 2017
30 tablet, coated in 1 bottle72241-010-22Modavar Pharmaceuticals30 December 2017
2000 tablet, film coated in 1 bottle50228-306-20ScieGen Pharmaceuticals12 October 2016
30 tablet, film coated in 1 bottle50228-306-30ScieGen Pharmaceuticals12 October 2016
100 tablet, film coated in 1 bottle0093-7290-01Teva Pharmaceuticals28 March 2014
30 tablet, film coated in 1 bottle0093-7290-56Teva Pharmaceuticals28 March 2014
60 tablet, film coated in 1 bottle71335-1460-1Bryant Ranch Prepack3 January 2020
30 tablet, film coated in 1 bottle71335-1460-2Bryant Ranch Prepack28 December 2021
60 tablet, film coated in 1 bottle71335-1715-1Bryant Ranch Prepack2 October 2020
30 tablet, film coated in 1 bottle71335-1715-2Bryant Ranch Prepack29 December 2021
60 tablet, film coated in 1 bottle71335-2059-1Bryant Ranch Prepack3 March 2022
30 tablet, film coated in 1 bottle71335-2059-2Bryant Ranch Prepack27 February 2024

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 9 December 1997Drugs@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 Raloxifene 60 mg tablet.

Compare 1

Clinical summary

Raloxifene is an estrogen agonist/antagonist indicated for treatment and prevention of osteoporosis in postmenopausal women, among other approved uses. It is available as tablets for oral use. MedsAcross supplies Raloxifene 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 Raloxifene

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

Data sources

Need Raloxifene 60 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.