Sirolimus
These highlights do not include all the information needed to use SIROLIMUS TABLETS safely and effectively. See full prescribing information for SIROLIMUS TABLETS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 1999
Approved
Approval ID
5df60452-2b16-4ce9-8c29-48798a59d718
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 16, 2024
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sirolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68084-915
Application NumberANDA201578
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sirolimus
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 16, 2024
FDA Product Classification
INGREDIENTS (20)
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
POLYETHYLENE GLYCOL 20000Inactive
Code: 5WKN5KL2O8
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USF
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SIROLIMUSActive
Quantity: 1 mg in 1 1
Code: W36ZG6FT64
Classification: ACTIB