Medicine
Tacrolimus 0.1% ointment
Tacrolimus 0.1% ointment is a generic prescription medicine for topical use, made by 5 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 25°C (77°F): excursions permitted to 15°C to 30°C (59°F to 86°F)…
Key facts
- Active ingredient (INN)
- Tacrolimus
- Brand
- Sold under the generic name
- Strength
- 0.1%
- Dosage form
- Ointment
- Route
- Topical
- Packs
- 1 tube and 12 more
- Manufacturers
- Accord HealthcareIndiaGlenmark PharmaceuticalsIndiaE. FougeraEncube EthicalsPadagis Israel Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F): excursions permitted to 15°C to 30°C (59°F to 86°F) Manufactured for: Accord Healthcare, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, USA.
- 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
- 9 September 2014
- Identifiers
- RxCUI 313189, 314266DailyMed set ID 80e6817a-9b1e-4f0f-e053-2a91aa0a3d15, 43b38551-6c5e-48a4-a453-9286f1c16b34, 6b601eaf-4f3a-4a8b-8cd8-1000defa9822 +2NDC 16729-422, 21922-011, 45802-700 +2Application ANDA211688, ANDA212387, NDA050777 +2
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 |
|---|---|---|---|
| 1 tube in 1 carton / 100 g in 1 tube | 16729-422-01 | Accord HealthcareIndia | 5 June 2019 |
| 1 tube in 1 carton / 30 g in 1 tube | 16729-422-10 | Accord HealthcareIndia | 31 May 2019 |
| 1 tube in 1 carton / 60 g in 1 tube | 16729-422-12 | Accord HealthcareIndia | 31 May 2019 |
| 1 tube in 1 carton / 30 g in 1 tube | 68462-534-35 | Glenmark PharmaceuticalsIndia | 16 April 2018 |
| 1 tube in 1 carton / 60 g in 1 tube | 68462-534-65 | Glenmark PharmaceuticalsIndia | 16 April 2018 |
| 1 tube in 1 carton / 100 g in 1 tube | 68462-534-94 | Glenmark PharmaceuticalsIndia | 16 April 2018 |
| 1 tube in 1 carton / 30 g in 1 tube | 0168-0416-30 | E. Fougera | 9 September 2014 |
| 1 tube in 1 carton / 60 g in 1 tube | 0168-0416-60 | E. Fougera | 9 September 2014 |
| 1 tube in 1 carton / 100 g in 1 tube | 0168-0416-99 | E. Fougera | 9 September 2014 |
| 1 tube in 1 carton / 30 g in 1 tube | 21922-011-05 | Encube Ethicals | 13 October 2023 |
| 1 tube in 1 carton / 60 g in 1 tube | 21922-011-07 | Encube Ethicals | 13 October 2023 |
| 1 tube in 1 carton / 100 g in 1 tube | 21922-011-09 | Encube Ethicals | 13 October 2023 |
| 1 tube in 1 carton / 30 g in 1 tube | 45802-700-00 | Padagis Israel Pharmaceuticals | 20 November 2014 |
| 1 tube in 1 carton / 60 g in 1 tube | 45802-700-01 | Padagis Israel Pharmaceuticals | 20 November 2014 |
| 1 tube in 1 carton / 100 g in 1 tube | 45802-700-02 | Padagis Israel Pharmaceuticals | 20 November 2014 |
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
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 0.1% ointment 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.