Zosyn
These highlights do not include all the information needed to use ZOSYN safely and effectively. See full prescribing information for ZOSYN. Initial U.S. Approval: 1993
Approved
Approval ID
8db6bd91-2106-4bfd-8cc8-38aaf1e18d17
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 1, 2023
Manufacturers
FDA
Baxter Healthcare Corporation
DUNS: 005083209
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
piperacillin sodium and tazobactam sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0338-9636
Application NumberNDA050750
Product Classification
M
Marketing Category
C73594
G
Generic Name
piperacillin sodium and tazobactam sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 1, 2023
FDA Product Classification
INGREDIENTS (8)
PIPERACILLIN SODIUMActive
Quantity: 3 g in 50 mL
Code: M98T69Q7HP
Classification: ACTIM
DEXTROSE MONOHYDRATEInactive
Quantity: 350 mg in 50 mL
Code: LX22YL083G
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.75 mg in 50 mL
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
TAZOBACTAM SODIUMActive
Quantity: 0.375 g in 50 mL
Code: UXA545ABTT
Classification: ACTIM
SODIUM CITRATE, UNSPECIFIED FORMInactive
Quantity: 150 mg in 50 mL
Code: 1Q73Q2JULR
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
piperacillin sodium and tazobactam sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0338-9638
Application NumberNDA050750
Product Classification
M
Marketing Category
C73594
G
Generic Name
piperacillin sodium and tazobactam sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 1, 2023
FDA Product Classification
INGREDIENTS (8)
TAZOBACTAM SODIUMActive
Quantity: 0.5 g in 100 mL
Code: UXA545ABTT
Classification: ACTIM
PIPERACILLIN SODIUMActive
Quantity: 4 g in 100 mL
Code: M98T69Q7HP
Classification: ACTIM
SODIUM CITRATE, UNSPECIFIED FORMInactive
Quantity: 200 mg in 100 mL
Code: 1Q73Q2JULR
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 1 mg in 100 mL
Code: 7FLD91C86K
Classification: IACT
DEXTROSE MONOHYDRATEInactive
Quantity: 2 g in 100 mL
Code: LX22YL083G
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
piperacillin sodium and tazobactam sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0338-9632
Application NumberNDA050750
Product Classification
M
Marketing Category
C73594
G
Generic Name
piperacillin sodium and tazobactam sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 1, 2023
FDA Product Classification
INGREDIENTS (8)
PIPERACILLIN SODIUMActive
Quantity: 2 g in 50 mL
Code: M98T69Q7HP
Classification: ACTIM
DEXTROSE MONOHYDRATEInactive
Quantity: 1 g in 50 mL
Code: LX22YL083G
Classification: IACT
TAZOBACTAM SODIUMActive
Quantity: 0.25 g in 50 mL
Code: UXA545ABTT
Classification: ACTIM
SODIUM CITRATE, UNSPECIFIED FORMInactive
Quantity: 100 mg in 50 mL
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.5 mg in 50 mL
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT