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Medicine

Tadalafil 10 mg tablet

Tadalafil · Oral
Available on requestPrescription onlyUS FDAGeneric name

Tadalafil 10 mg tablet is a generic prescription medicine for oral use, made by 35 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 25°C (77°F), excursions permitted to 15-30°C (59-86°F).

Key facts

Active ingredient (INN)
Tadalafil
Brand
Sold under the generic name
Strength
10 mg
Dosage form
Tablet
Route
Oral
Packs
30 tablets, 500 tablets, 1000 tablets and 142 more
Manufacturers
Zydus LifesciencesIndiaAlembic PharmaceuticalsIndiaUmedica LaboratoriesIndiaAurobindo PharmaIndiaAccord HealthcareIndiaAjanta PharmaIndiaCamber PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaMacleods PharmaceuticalsIndiaTorrent PharmaceuticalsIndia35 labelers on the register
Origin register
US FDA, United States
Storage
Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
G04BE08 Tadalafil
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
26 March 2019
Identifiers
RxCUI 402019, 403957, 484814 +1DailyMed set ID b4d9851c-5c06-4532-bd82-16d92b60c28f, 6c680b37-d515-4fc2-83e6-411f1017e18c, add6afb8-d38c-47a2-8c35-d5940667bb0c +37NDC 71821-008, 72789-430, 72865-107 +37Application ANDA215556, ANDA209908, ANDA210420 +18

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 35 labelers. The register lists 145 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
30 tablet, coated in 1 bottle46708-179-30Alembic PharmaceuticalsIndia26 March 2019
500 tablet, coated in 1 bottle46708-179-71Alembic PharmaceuticalsIndia3 September 2024
1000 tablet, coated in 1 bottle46708-179-91Alembic PharmaceuticalsIndia3 September 2024
30 tablet, coated in 1 bottle62332-179-30Alembic PharmaceuticalsIndia26 March 2019
500 tablet, coated in 1 bottle62332-179-71Alembic PharmaceuticalsIndia3 September 2024
1000 tablet, coated in 1 bottle62332-179-91Alembic PharmaceuticalsIndia3 September 2024
100 tablet, film coated in 1 bottle68382-898-01Zydus LifesciencesIndia27 March 2019
500 tablet, film coated in 1 bottle68382-898-05Zydus LifesciencesIndia27 March 2019
30 tablet, film coated in 1 bottle68382-898-06Zydus LifesciencesIndia27 March 2019
1000 tablet, film coated in 1 bottle68382-898-10Zydus LifesciencesIndia27 March 2019
90 tablet, film coated in 1 bottle68382-898-16Zydus LifesciencesIndia27 March 2019
2 blister pack in 1 carton / 15 tablet, film coated in 1 blister pack68382-898-99Zydus LifesciencesIndia27 March 2019
1000 tablet, film coated in 1 bottle70771-1477-0Zydus LifesciencesIndia27 March 2019
100 tablet, film coated in 1 bottle70771-1477-1Zydus LifesciencesIndia27 March 2019
30 tablet, film coated in 1 bottle70771-1477-3Zydus LifesciencesIndia27 March 2019
2 blister pack in 1 carton / 15 tablet, film coated in 1 blister pack70771-1477-4Zydus LifesciencesIndia27 March 2019
500 tablet, film coated in 1 bottle70771-1477-5Zydus LifesciencesIndia27 March 2019
90 tablet, film coated in 1 bottle70771-1477-9Zydus LifesciencesIndia27 March 2019
30 tablet, film coated in 1 bottle16729-371-10Accord HealthcareIndia3 April 2020
500 tablet, film coated in 1 bottle16729-371-16Accord HealthcareIndia29 April 2020
30 tablet in 1 bottle27241-113-03Ajanta PharmaIndia26 March 2019
500 tablet in 1 bottle27241-113-05Ajanta PharmaIndia17 June 2020
500 tablet, film coated in 1 bottle65862-852-05Aurobindo PharmaIndia26 March 2019
30 tablet, film coated in 1 bottle65862-852-30Aurobindo PharmaIndia26 March 2019
1000 tablet, film coated in 1 bottle65862-852-99Aurobindo PharmaIndia26 March 2019
30 tablet, film coated in 1 bottle31722-645-30Camber PharmaceuticalsIndia26 March 2019
10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack31722-645-31Camber PharmaceuticalsIndia26 March 2019
30 tablet, film coated in 1 bottle43598-574-30Dr. Reddy's LaboratoriesIndia26 March 2019
3 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack43598-574-31Dr. Reddy's LaboratoriesIndia7 April 2020
30 tablet, film coated in 1 bottle82968-003-01Fourrts (India) LaboratoriesIndia21 August 2024
30 tablet, film coated in 1 bottle33342-267-07Macleods PharmaceuticalsIndia8 October 2019
1000 tablet, film coated in 1 bottle33342-267-44Macleods PharmaceuticalsIndia17 April 2025
30 tablet, film coated in 1 bottle47335-011-83Sun Pharmaceutical IndustriesIndia26 March 2019
500 tablet in 1 bottle13668-567-05Torrent PharmaceuticalsIndia26 March 2019
30 tablet in 1 bottle13668-567-30Torrent PharmaceuticalsIndia26 March 2019
30 tablet, film coated in 1 bottle60290-029-01Umedica LaboratoriesIndia15 February 2026
1000 tablet, film coated in 1 bottle60290-029-02Umedica LaboratoriesIndia15 February 2026
30 tablet, film coated in 1 blister pack60290-029-03Umedica LaboratoriesIndia15 February 2026
500 tablet, film coated in 1 bottle60290-029-04Umedica LaboratoriesIndia24 April 2026
100 tablet, film coated in 1 bottle, plastic29300-288-01Unichem LaboratoriesIndia26 March 2019

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 21 November 2003Drugs@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 Tadalafil 10 mg tablet.

Compare 1

Other strengths and forms of Tadalafil

Clinical summary

Tadalafil is a phosphodiesterase 5 inhibitor indicated for the treatment of erectile dysfunction (ED) the signs and symptoms of benign prostatic hyperplasia (BPH), among other approved uses. It is available as tablets and oral suspension. MedsAcross supplies Tadalafil 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 Tadalafil

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

Data sources

Need Tadalafil 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.