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
1bef7d8f-524b-4218-8fef-6c3f3628d33e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 21, 2022
Manufacturers
FDA
Major Pharmaceuticals
DUNS: 191427277
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sirolimus
PRODUCT DETAILS
NDC Product Code0904-7248
Application NumberANDA214753
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 21, 2022
Generic NameSirolimus
INGREDIENTS (16)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SIROLIMUSActive
Quantity: 1 mg in 1 1
Code: W36ZG6FT64
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GLYCERYL MONOCAPRYLOCAPRATEInactive
Code: G7515SW10N
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT