tacrolimus
tacrolimus is listed in the FDA National Drug Code directory with 10 NDC codes, marketed under brand names including tacrolimus, Tacrolimus. Available dosage forms: capsule, ointment, powder.
Drug Details
- Generic Name
- tacrolimus
- Brand Names
- tacrolimus, Tacrolimus
- Application Number
- ANDA206662
- Sponsor
- NORTHSTAR RX LLC
- NDC Codes
- 10
- Dosage Forms
- CAPSULE, OINTMENT, POWDER
- Routes
- ORAL, TOPICAL
- Active Ingredients
- TACROLIMUS
Indications and Usage
1 INDICATIONS AND USAGE Tacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney or heart transplants in combination with other immunosuppressants. ( 1.1 ) 1.1 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 [see Clinical Studies ( 14.1 )] , liver transplant [see Clinical Studies ( 14.2 )] and heart transplant [see Clinical Studies ( 14.3 )] in combination with other immunosuppressants.