Prograf
PROGRAF®tacrolimus capsulestacrolimus injection (for intravenous infusion only)
Approved
Approval ID
f15b043d-fcfa-4ade-a3da-76700c0c5c2a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tacrolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-170
Application NumberNDA050708
Product Classification
M
Marketing Category
C73594
G
Generic Name
Tacrolimus
Product Specifications
Route of AdministrationORAL
Effective DateJune 19, 2006
FDA Product Classification
INGREDIENTS (7)
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
anhydrous tacrolimusActive
Quantity: 1 mg in 1 1
Code: Y5L2157C4J
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT