tacrolimus extended-release capsules
tacrolimus extended-release capsules is listed in the FDA National Drug Code directory with 6 NDC codes, marketed under brand names including ASTAGRAF XL, tacrolimus. Available dosage form: capsule, coated, extended release.
Drug Details
- Generic Name
- tacrolimus extended-release capsules
- Brand Names
- ASTAGRAF XL, tacrolimus
- Application Number
- NDA204096
- Sponsor
- Astellas Pharma US, Inc.
- NDC Codes
- 6
- Dosage Forms
- CAPSULE, COATED, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- TACROLIMUS
Indications and Usage
1 INDICATIONS AND USAGE Tacrolimus extended-release capsules is indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants in adult patients who can swallow capsules intact [see Clinical Studies ( 14.1 ), ( 14.2 )] . Pediatric use information is approved for Astellas Pharma US, Inc.'s ASTAGRAF XL (tacrolimus extended-release capsules). However, due to Astellas Pharma US, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. Tacrolimus extended-release capsules is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants in adult patients who can swallow capsules intact. ( 1 , 14.1 , 14.2 )