SIRTURO
These highlights do not include all the information needed to use SIRTURO safely and effectively. See full prescribing information for SIRTURO. SIRTURO (bedaquiline) tablets, for oral use Initial U.S. Approval: 2012
Approved
Approval ID
1534c9ae-4948-4cf4-9f66-222a99db6d0e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 17, 2023
Manufacturers
FDA
Janssen Products, LP
DUNS: 804684207
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bedaquiline Fumarate
PRODUCT DETAILS
NDC Product Code59676-702
Application NumberNDA204384
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 17, 2023
Generic NameBedaquiline Fumarate
INGREDIENTS (8)
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
BEDAQUILINE FUMARATEActive
Quantity: 20 mg in 1 1
Code: P04QX2C1A5
Classification: ACTIM
Bedaquiline Fumarate
PRODUCT DETAILS
NDC Product Code59676-701
Application NumberNDA204384
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 17, 2023
Generic NameBedaquiline Fumarate
INGREDIENTS (10)
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BEDAQUILINE FUMARATEActive
Quantity: 100 mg in 1 1
Code: P04QX2C1A5
Classification: ACTIM