SIVEXTRO
These highlights do not include all the information needed to use SIVEXTRO safely and effectively. See full prescribing information for SIVEXTRO. SIVEXTRO (tedizolid phosphate) for injection, for intravenous use SIVEXTRO (tedizolid phosphate) tablet, for oral use Initial U.S. Approval: 2014
Approved
Approval ID
11d5c110-c48c-438f-9c7d-5adf99938534
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 25, 2022
Manufacturers
FDA
Nabriva Therapeutics US, Inc.
DUNS: 072863844
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tedizolid phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72000-310
Application NumberNDA205435
Product Classification
M
Marketing Category
C73594
G
Generic Name
tedizolid phosphate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 25, 2022
FDA Product Classification
INGREDIENTS (11)
TEDIZOLID PHOSPHATEActive
Quantity: 200 mg in 1 1
Code: O7DRJ6R4DW
Classification: ACTIB
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
tedizolid phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72000-320
Application NumberNDA205436
Product Classification
M
Marketing Category
C73594
G
Generic Name
tedizolid phosphate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 25, 2022
FDA Product Classification
INGREDIENTS (4)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TEDIZOLID PHOSPHATEActive
Quantity: 200 mg in 4 mL
Code: O7DRJ6R4DW
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
MANNITOLInactive
Quantity: 105 mg in 4 mL
Code: 3OWL53L36A
Classification: IACT