Medicine
Tacrolimus 5 mg capsule
Tacrolimus 5 mg capsule is a generic prescription medicine for oral use, made by 22 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 and Dispense Store at 20°C to 25°C (68°F to 77°F).
Key facts
- Active ingredient (INN)
- Tacrolimus
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 50 blister pack, 30 capsules and 27 more
- Manufacturers
- Dr. Reddy's LaboratoriesIndiaAscend LaboratoriesIndiaConcord BiotechIndiaGlenmark PharmaceuticalsIndiaStrides PharmaIndiaAccord HealthcareIndiaBioconIndiaJubilant Cadista PharmaceuticalsIndiaPanacea BiotecIndiaStellon Biotech
- Origin register
- US FDA, United States
- Storage
- Store and Dispense Store at 20°C to 25°C (68°F to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D11AH01 Tacrolimus
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 10 August 2009
- Identifiers
- RxCUI 198377, 198378, 313190 +3DailyMed set ID 61dee012-43af-0e9a-3843-9b9b91e022c4, ca08d4aa-3de2-4a9d-9554-6288e5d36f29, 875f4962-557e-4e12-ad7b-cb5fb6f2a65f +19NDC 55111-527, 82983-402, 16714-100 +19Application ANDA090509, ANDA206651, ANDA206662 +8
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.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 capsule in 1 bottle | 16729-043-01 | Accord HealthcareIndia | 30 September 2011 |
| 100 capsule in 1 bottle | 67877-280-01 | Ascend LaboratoriesIndia | 13 November 2020 |
| 50 blister pack in 1 carton / 1 capsule in 1 blister pack | 67877-280-33 | Ascend LaboratoriesIndia | 13 November 2020 |
| 100 capsule in 1 bottle | 70377-016-11 | BioconIndia | 23 December 2020 |
| 100 capsule in 1 bottle | 68254-5006-1 | Concord BiotechIndia | 23 November 2020 |
| 30 capsule in 1 bottle | 68254-5006-5 | Concord BiotechIndia | 23 November 2020 |
| 1 bottle in 1 carton / 100 capsule in 1 bottle | 55111-527-01 | Dr. Reddy's LaboratoriesIndia | 14 May 2010 |
| 1 bottle in 1 carton / 500 capsule in 1 bottle | 55111-527-05 | Dr. Reddy's LaboratoriesIndia | 14 May 2010 |
| 1 bottle in 1 carton / 30 capsule in 1 bottle | 55111-527-30 | Dr. Reddy's LaboratoriesIndia | 14 May 2010 |
| 10 blister pack in 1 carton / 10 capsule in 1 blister pack | 55111-527-78 | Dr. Reddy's LaboratoriesIndia | 14 May 2010 |
| 100 capsule in 1 bottle | 68462-687-01 | Glenmark PharmaceuticalsIndia | 10 November 2020 |
| 10 blister pack in 1 carton / 10 capsule in 1 blister pack | 68462-687-14 | Glenmark PharmaceuticalsIndia | 10 November 2020 |
| 100 capsule, gelatin coated in 1 bottle | 59746-800-01 | Jubilant Cadista PharmaceuticalsIndia | 30 November 2024 |
| 100 capsule, gelatin coated in 1 bottle | 43817-423-01 | Panacea BiotecIndia | 26 February 2016 |
| 10 blister pack in 1 carton / 10 capsule in 1 blister pack | 64380-722-01 | Strides PharmaIndia | 5 October 2020 |
| 100 capsule in 1 container | 64380-722-06 | Strides PharmaIndia | 5 October 2020 |
| 100 capsule in 1 bottle | 82983-402-10 | Ajenat Pharmaceuticals | 31 January 2023 |
| 100 capsule in 1 bottle | 54288-133-01 | BPI Labs | 8 April 2020 |
| 100 capsule in 1 bottle, plastic | 0378-2047-01 | Mylan Pharmaceuticals | 17 September 2010 |
| 100 blister pack in 1 carton / 1 capsule in 1 blister pack | 51079-028-20 | MylanInstitutional | 1 November 2010 |
| 100 capsule in 1 bottle | 0781-2104-01 | Sandoz | 10 August 2009 |
| 100 capsule in 1 bottle | 85972-103-01 | Stellon Biotech | 7 August 2025 |
| 30 capsule in 1 bottle | 85972-103-30 | Stellon Biotech | 7 August 2025 |
| 100 blister pack in 1 box, unit-dose / 1 capsule in 1 blister pack | 68084-451-01 | American Health Packaging | 3 August 2010 |
| 100 capsule in 1 bottle | 63629-8726-1 | Bryant Ranch Prepack | 5 September 2024 |
| 100 capsule in 1 bottle, plastic | 60429-379-01 | Golden State Medical Supply | 18 November 2015 |
| 100 blister pack in 1 carton / 1 capsule in 1 blister pack | 0904-6624-61 | Major Pharmaceuticals | 14 May 2010 |
| 100 capsule in 1 bottle | 16714-100-01 | Northstar RX | 31 March 2021 |
| 100 capsule in 1 bottle | 82009-165-01 | Quallent Pharmaceuticals Health | 1 June 2025 |
| 100 blister pack in 1 carton / 1 capsule in 1 blister pack | 48433-094-20 | Safecor Health | 13 March 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.
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 Tacrolimus 5 mg capsule.
Other strengths and forms of Tacrolimus
Clinical summary
Tacrolimus is a calcineurin inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants. MedsAcross supplies Tacrolimus 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 TacrolimusFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Prograf prescribing information (Astellas Pharma) · U.S. National Library of Medicine, DailyMed
- Advagraf: European public assessment report (EPAR) · European Medicines Agency
- Envarsus: European public assessment report (EPAR) · European Medicines Agency
Need Tacrolimus 5 mg capsule 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.