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Medicine

Dapagliflozin 10 mg tablet

Available on requestPrescription onlyUS FDAGeneric name

Dapagliflozin 10 mg tablet is a generic prescription medicine for oral use, made by 18 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)
Dapagliflozin
Brand
Sold under the generic name
Strength
10 mg
Dosage form
Tablet
Route
Oral
Packs
30 tablets, 90 tablets, 1000 tablets and 43 more
Manufacturers
Alembic PharmaceuticalsIndiaAscend LaboratoriesIndiaZydus LifesciencesIndiaMacleods PharmaceuticalsIndiaMicro LabsIndiaNovadoz PharmaceuticalsIndiaAjanta PharmaIndiaAurobindo PharmaIndiaLupinIndiaSandoz18 labelers on the register
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
A10BK01 Dapagliflozin
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
6 April 2026
Identifiers
RxCUI 1488569, 1488574DailyMed set ID 5b436e9d-4299-de51-e063-6294a90a1ca0, b6b8a10c-64c3-4856-8961-d72d68784f5d, bd9766c5-104f-4636-897d-b6c92eb94f18 +17NDC 67296-2334, 67877-609, 60505-4912 +17Application ANDA211506, ANDA211545, ANDA211523 +10

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 18 labelers. The register lists 46 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
30 tablet, film coated in 1 bottle46708-393-30Alembic PharmaceuticalsIndia6 April 2026
90 tablet, film coated in 1 bottle46708-393-90Alembic PharmaceuticalsIndia20 April 2026
1000 tablet, film coated in 1 bottle46708-393-91Alembic PharmaceuticalsIndia6 April 2026
30 tablet, film coated in 1 bottle62332-393-30Alembic PharmaceuticalsIndia6 April 2026
90 tablet, film coated in 1 bottle62332-393-90Alembic PharmaceuticalsIndia20 April 2026
1000 tablet, film coated in 1 bottle62332-393-91Alembic PharmaceuticalsIndia6 April 2026
30 tablet in 1 bottle70710-1381-3Zydus LifesciencesIndia6 April 2026
90 tablet in 1 bottle70710-1381-9Zydus LifesciencesIndia6 April 2026
30 tablet in 1 bottle70771-1715-3Zydus LifesciencesIndia6 April 2026
90 tablet in 1 bottle70771-1715-9Zydus LifesciencesIndia6 April 2026
30 tablet in 1 bottle27241-152-01Ajanta PharmaIndia6 April 2026
90 tablet in 1 bottle27241-152-90Ajanta PharmaIndia2 September 2026
500 tablet, film coated in 1 bottle67877-609-05Ascend LaboratoriesIndia6 April 2026
30 tablet, film coated in 1 bottle67877-609-30Ascend LaboratoriesIndia6 April 2026
1 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack67877-609-33Ascend LaboratoriesIndia6 April 2026
90 tablet, film coated in 1 bottle67877-609-90Ascend LaboratoriesIndia6 April 2026
30 tablet, film coated in 1 bottle59651-160-30Aurobindo PharmaIndia6 April 2026
90 tablet, film coated in 1 bottle59651-160-90Aurobindo PharmaIndia8 May 2026
30 tablet in 1 bottle70748-106-06LupinIndia8 April 2026
30 tablet in 1 bottle33342-586-07Macleods PharmaceuticalsIndia6 April 2026
90 tablet in 1 bottle33342-586-10Macleods PharmaceuticalsIndia6 April 2026
10 blister pack in 1 carton / 14 tablet in 1 blister pack33342-586-56Macleods PharmaceuticalsIndia6 April 2026
1000 tablet in 1 bottle42571-318-10Micro LabsIndia1 October 2026
30 tablet in 1 bottle42571-318-30Micro LabsIndia1 October 2026
90 tablet in 1 bottle42571-318-90Micro LabsIndia1 October 2026
30 tablet, film coated in 1 bottle72205-433-01Novadoz PharmaceuticalsIndia7 April 2026
500 tablet, film coated in 1 bottle72205-433-02Novadoz PharmaceuticalsIndia7 April 2026
90 tablet, film coated in 1 bottle72205-433-03Novadoz PharmaceuticalsIndia7 April 2026
30 tablet, film coated in 1 bottle70954-857-10ANI Pharmaceuticals13 May 2026
30 tablet, film coated in 1 bottle, plastic60505-4912-3Apotex8 April 2026
90 tablet in 1 bottle71921-421-09Florida Pharmaceutical Products6 April 2026
30 tablet in 1 bottle71921-421-33Florida Pharmaceutical Products6 April 2026
500 tablet in 1 bottle71921-421-50Florida Pharmaceutical Products6 April 2026
100 tablet, film coated in 1 bottle, plastic0781-5990-01Sandoz6 April 2026
500 tablet, film coated in 1 bottle, plastic0781-5990-05Sandoz6 April 2026
1000 tablet, film coated in 1 bottle, plastic0781-5990-10Sandoz6 April 2026
30 tablet, film coated in 1 bottle, plastic0781-5990-31Sandoz6 April 2026
500 tablet, film coated in 1 bottle0480-3528-05Teva Pharmaceuticals14 May 2026
30 tablet, film coated in 1 bottle0480-3528-56Teva Pharmaceuticals8 April 2026
90 tablet, film coated in 1 bottle0480-3528-98Teva Pharmaceuticals27 April 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 8 January 2014Drugs@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

Other strengths and forms of Dapagliflozin

Clinical summary

Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor indicated to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular (CV) disease or multiple CV risk factors. MedsAcross supplies Dapagliflozin 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 Dapagliflozin

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

Data sources

Need Dapagliflozin 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.