ASTAGRAF XL
These highlights do not include all the information needed to use ASTAGRAF XL safely and effectively. See full prescribing information for ASTAGRAF XL. ASTAGRAF XL (tacrolimus extended-release capsules), for oral useInitial U.S. Approval: 1994
Approved
Approval ID
550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 25, 2023
Manufacturers
FDA
Astellas Pharma US, Inc.
DUNS: 605764828
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tacrolimus extended-release capsules
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0469-0677
Application NumberNDA204096
Product Classification
M
Marketing Category
C73594
G
Generic Name
tacrolimus extended-release capsules
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2020
FDA Product Classification
INGREDIENTS (1)
TACROLIMUSActive
Quantity: 1 mg in 1 1
Code: WM0HAQ4WNM
Classification: ACTIM
tacrolimus extended-release capsules
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0469-0687
Application NumberNDA204096
Product Classification
M
Marketing Category
C73594
G
Generic Name
tacrolimus extended-release capsules
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2020
FDA Product Classification
INGREDIENTS (1)
TACROLIMUSActive
Quantity: 5 mg in 1 1
Code: WM0HAQ4WNM
Classification: ACTIM
tacrolimus extended-release capsules
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0469-0647
Application NumberNDA204096
Product Classification
M
Marketing Category
C73594
G
Generic Name
tacrolimus extended-release capsules
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2020
FDA Product Classification
INGREDIENTS (1)
TACROLIMUSActive
Quantity: 0.5 mg in 1 1
Code: WM0HAQ4WNM
Classification: ACTIM