UNASYN
UNASYN (ampicillin sodium/sulbactam sodium)
Approved
Approval ID
155c7ec0-5862-404f-b1d0-f278f8a8bbda
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 6, 2023
Manufacturers
FDA
Roerig
DUNS: 829076996
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ampicillin sodium and sulbactam sodium
PRODUCT DETAILS
NDC Product Code0049-0014
Application NumberNDA050608
Marketing CategoryC73594
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMarch 29, 2023
Generic Nameampicillin sodium and sulbactam sodium
INGREDIENTS (2)
AMPICILLIN SODIUMActive
Quantity: 2 g in 1 1
Code: JFN36L5S8K
Classification: ACTIM
SULBACTAM SODIUMActive
Quantity: 1 g in 1 1
Code: DKQ4T82YE6
Classification: ACTIM
ampicillin sodium and sulbactam sodium
PRODUCT DETAILS
NDC Product Code0049-0031
Application NumberANDA062901
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMarch 29, 2023
Generic Nameampicillin sodium and sulbactam sodium
INGREDIENTS (2)
SULBACTAM SODIUMActive
Quantity: 0.5 g in 1 1
Code: DKQ4T82YE6
Classification: ACTIM
AMPICILLIN SODIUMActive
Quantity: 1 g in 1 1
Code: JFN36L5S8K
Classification: ACTIM
ampicillin sodium and sulbactam sodium
PRODUCT DETAILS
NDC Product Code0049-0032
Application NumberANDA062901
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMarch 29, 2023
Generic Nameampicillin sodium and sulbactam sodium
INGREDIENTS (2)
AMPICILLIN SODIUMActive
Quantity: 2 g in 1 1
Code: JFN36L5S8K
Classification: ACTIM
SULBACTAM SODIUMActive
Quantity: 1 g in 1 1
Code: DKQ4T82YE6
Classification: ACTIM
ampicillin sodium and sulbactam sodium
PRODUCT DETAILS
NDC Product Code0049-0013
Application NumberNDA050608
Marketing CategoryC73594
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMarch 29, 2023
Generic Nameampicillin sodium and sulbactam sodium
INGREDIENTS (2)
AMPICILLIN SODIUMActive
Quantity: 1 g in 1 1
Code: JFN36L5S8K
Classification: ACTIM
SULBACTAM SODIUMActive
Quantity: 0.5 g in 1 1
Code: DKQ4T82YE6
Classification: ACTIM