Prograf
These highlights do not include all the information needed to use PROGRAF safely and effectively. See full prescribing information for PROGRAF. PROGRAF (tacrolimus) capsules, for oral usePROGRAF (tacrolimus) injection, for intravenous usePROGRAF Granules (tacrolimus for oral suspension)Initial U.S. Approval: 1994
Approved
Approval ID
7f667de1-9dfa-4bd6-8ba0-15ee2d78873b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 25, 2023
Manufacturers
FDA
Astellas Pharma US, Inc.
DUNS: 605764828
Products 6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tacrolimus
PRODUCT DETAILS
NDC Product Code0469-1330
Application NumberNDA210115
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateMay 31, 2022
Generic NameTacrolimus
INGREDIENTS (4)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TACROLIMUSActive
Quantity: 1 mg in 1 1
Code: WM0HAQ4WNM
Classification: ACTIM
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
Tacrolimus
PRODUCT DETAILS
NDC Product Code0469-3016
Application NumberNDA050709
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateMay 31, 2022
Generic NameTacrolimus
INGREDIENTS (3)
TACROLIMUSActive
Quantity: 5 mg in 1 mL
Code: WM0HAQ4WNM
Classification: ACTIM
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PEG-60 HYDROGENATED CASTOR OILInactive
Code: 02NG325BQG
Classification: IACT
Tacrolimus
PRODUCT DETAILS
NDC Product Code0469-1230
Application NumberNDA210115
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateMay 31, 2022
Generic NameTacrolimus
INGREDIENTS (4)
TACROLIMUSActive
Quantity: 0.2 mg in 1 1
Code: WM0HAQ4WNM
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Tacrolimus
PRODUCT DETAILS
NDC Product Code0469-0657
Application NumberNDA050708
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateMay 31, 2022
Generic NameTacrolimus
INGREDIENTS (1)
TACROLIMUSActive
Quantity: 5 mg in 1 1
Code: WM0HAQ4WNM
Classification: ACTIM
Tacrolimus
PRODUCT DETAILS
NDC Product Code0469-0617
Application NumberNDA050708
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateMay 31, 2022
Generic NameTacrolimus
INGREDIENTS (1)
TACROLIMUSActive
Quantity: 1 mg in 1 1
Code: WM0HAQ4WNM
Classification: ACTIM
Tacrolimus
PRODUCT DETAILS
NDC Product Code0469-0607
Application NumberNDA050708
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateMay 31, 2022
Generic NameTacrolimus
INGREDIENTS (1)
TACROLIMUSActive
Quantity: 0.5 mg in 1 1
Code: WM0HAQ4WNM
Classification: ACTIM