Medicine
Tadalafil 5 mg tablet
Tadalafil 5 mg tablet is a generic prescription medicine for oral use, made by 40 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
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 to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Tadalafil
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 500 tablets, 1000 tablets and 169 more
- Manufacturers
- Zydus LifesciencesIndiaAlembic PharmaceuticalsIndiaAccord HealthcareIndiaAjanta PharmaIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaFourrts (India) LaboratoriesIndiaMacleods PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndia40 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 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 a0f728b6-2cc6-cb65-e053-2a95a90ab142, dc14daa3-cae9-4751-9034-b0e9c18054b4, 3ea7612b-b004-43ef-accc-34c8ec5146b8 +37NDC 72303-0823, 82009-077, 13668-566 +37Application ANDA211335, ANDA209654, ANDA211839 +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 40 labelers. The register lists 172 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet, coated in 1 carton | 46708-178-15 | Alembic PharmaceuticalsIndia | 26 March 2019 |
| 30 tablet, coated in 1 bottle | 46708-178-30 | Alembic PharmaceuticalsIndia | 26 March 2019 |
| 500 tablet, coated in 1 bottle | 46708-178-71 | Alembic PharmaceuticalsIndia | 2 August 2024 |
| 1000 tablet, coated in 1 bottle | 46708-178-91 | Alembic PharmaceuticalsIndia | 2 August 2024 |
| 30 tablet, coated in 1 carton | 62332-178-15 | Alembic PharmaceuticalsIndia | 26 March 2019 |
| 30 tablet, coated in 1 bottle | 62332-178-30 | Alembic PharmaceuticalsIndia | 26 March 2019 |
| 500 tablet, coated in 1 bottle | 62332-178-71 | Alembic PharmaceuticalsIndia | 2 August 2024 |
| 1000 tablet, coated in 1 bottle | 62332-178-91 | Alembic PharmaceuticalsIndia | 2 August 2024 |
| 100 tablet, film coated in 1 bottle | 68382-897-01 | Zydus LifesciencesIndia | 27 March 2019 |
| 500 tablet, film coated in 1 bottle | 68382-897-05 | Zydus LifesciencesIndia | 27 March 2019 |
| 30 tablet, film coated in 1 bottle | 68382-897-06 | Zydus LifesciencesIndia | 27 March 2019 |
| 1000 tablet, film coated in 1 bottle | 68382-897-10 | Zydus LifesciencesIndia | 27 March 2019 |
| 90 tablet, film coated in 1 bottle | 68382-897-16 | Zydus LifesciencesIndia | 27 March 2019 |
| 10 tablet, film coated in 1 bottle | 68382-897-50 | Zydus LifesciencesIndia | 27 March 2019 |
| 2 blister pack in 1 carton / 15 tablet, film coated in 1 blister pack | 68382-897-99 | Zydus LifesciencesIndia | 27 March 2019 |
| 1000 tablet, film coated in 1 bottle | 70771-1476-0 | Zydus LifesciencesIndia | 27 March 2019 |
| 100 tablet, film coated in 1 bottle | 70771-1476-1 | Zydus LifesciencesIndia | 27 March 2019 |
| 30 tablet, film coated in 1 bottle | 70771-1476-3 | Zydus LifesciencesIndia | 27 March 2019 |
| 2 blister pack in 1 carton / 15 tablet, film coated in 1 blister pack | 70771-1476-4 | Zydus LifesciencesIndia | 27 March 2019 |
| 500 tablet, film coated in 1 bottle | 70771-1476-5 | Zydus LifesciencesIndia | 27 March 2019 |
| 10 tablet, film coated in 1 bottle | 70771-1476-7 | Zydus LifesciencesIndia | 27 March 2019 |
| 90 tablet, film coated in 1 bottle | 70771-1476-9 | Zydus LifesciencesIndia | 27 March 2019 |
| 30 tablet, film coated in 1 bottle | 16729-370-10 | Accord HealthcareIndia | 27 March 2019 |
| 500 tablet, film coated in 1 bottle | 16729-370-16 | Accord HealthcareIndia | 27 April 2020 |
| 30 tablet in 1 bottle | 27241-112-03 | Ajanta PharmaIndia | 26 March 2019 |
| 500 tablet in 1 bottle | 27241-112-05 | Ajanta PharmaIndia | 17 June 2020 |
| 30 tablet, film coated in 1 bottle | 65862-851-30 | Aurobindo PharmaIndia | 26 March 2019 |
| 2 blister pack in 1 carton / 15 tablet, film coated in 1 blister pack | 65862-851-32 | Aurobindo PharmaIndia | 26 March 2019 |
| 30 tablet, film coated in 1 bottle | 31722-644-30 | Camber PharmaceuticalsIndia | 26 March 2019 |
| 3 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 31722-644-31 | Camber PharmaceuticalsIndia | 26 March 2019 |
| 30 tablet, film coated in 1 bottle | 43598-575-30 | Dr. Reddy's LaboratoriesIndia | 26 March 2019 |
| 3 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 43598-575-31 | Dr. Reddy's LaboratoriesIndia | 7 April 2020 |
| 30 tablet, film coated in 1 bottle | 82968-002-01 | Fourrts (India) LaboratoriesIndia | 21 August 2024 |
| 2 blister pack in 1 carton / 15 tablet, film coated in 1 blister pack | 82968-002-02 | Fourrts (India) LaboratoriesIndia | 21 August 2024 |
| 30 tablet, film coated in 1 bottle | 33342-266-07 | Macleods PharmaceuticalsIndia | 8 October 2019 |
| 1000 tablet, film coated in 1 bottle | 33342-266-44 | Macleods PharmaceuticalsIndia | 17 April 2025 |
| 2 blister pack in 1 carton / 15 tablet, film coated in 1 blister pack | 47335-010-64 | Sun Pharmaceutical IndustriesIndia | 26 March 2019 |
| 30 tablet, film coated in 1 bottle | 47335-010-83 | Sun Pharmaceutical IndustriesIndia | 26 March 2019 |
| 500 tablet in 1 bottle | 13668-566-05 | Torrent PharmaceuticalsIndia | 26 March 2019 |
| 30 tablet in 1 bottle | 13668-566-30 | Torrent PharmaceuticalsIndia | 26 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.
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 5 mg tablet.
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 TadalafilFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Cialis prescribing information (Eli Lilly) · U.S. National Library of Medicine, DailyMed
- Adcirca (previously Tadalafil Lilly): European public assessment report (EPAR) · European Medicines Agency
- Cialis: European public assessment report (EPAR) · European Medicines Agency
Need Tadalafil 5 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.