NDC Code | 0469-0647-11 |
Package Description | 5 BLISTER PACK in 1 CARTON (0469-0647-11) / 10 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK |
Product NDC | 0469-0647 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Astagraf Xl |
Non-Proprietary Name | Tacrolimus Extended-release Capsules |
Dosage Form | CAPSULE, COATED, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20130719 |
Marketing Category Name | NDA |
Application Number | NDA204096 |
Manufacturer | Astellas Pharma US, Inc. |
Substance Name | TACROLIMUS |
Strength | .5 |
Strength Unit | mg/1 |
Pharmacy Classes | Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA] |