What is tacrolimus used for?

Indications and Usage, quoted from the label by Sandoz Inc. (ANDA065461). Cross-references to other label sections are left out.

Prophylaxis of Organ Rejection in Kidney, Liver, or Heart Transplant

Tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult and pediatric patients receiving allogeneic kidney transplant, liver transplant, or heart transplant in combination with other immunosuppressants.

Additional pediatric use information is approved for Astellas Pharma US, Inc.’s Prograf (tacrolimus) products. However, due to Astellas Pharma US, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

Source: DailyMed label, set id 46ac55cf-d85e-4c34-bb33-f49e078c4a03, version 23, effective July 24, 2026. NDC 0781-2102, one of 72 listings for this product.

Indications and Usage, quoted from the label by Glenmark Pharmaceuticals Inc., USA (ANDA210393). Cross-references to other label sections are left out.

Tacrolimus ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable.

Tacrolimus ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).

Source: DailyMed label, set id c2d2e3a1-f346-4245-b445-6dd44e371180, version 8, effective April 15, 2026. NDC 68462-534, one of 7 listings for this product.

Indications and Usage, quoted from the label by Panacea Biotec Limited (ANDA090802). Cross-references to other label sections are left out.

Prophylaxis of Organ Rejection in Kidney, Liver, or Heart Transplant

Tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult and pediatric patients receiving allogeneic kidney transplant, liver transplants, or heart transplant, in combination with other immunosuppressants.

Source: DailyMed label, set id bd9fea26-0236-d437-c7df-4b7636210875, version 16, effective October 15, 2026. NDC 43817-421, one of 6 listings for this product.