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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0049-0014
Application NumberNDA050608
Product Classification
M
Marketing Category
C73594
G
Generic Name
ampicillin sodium and sulbactam sodium
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMarch 29, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0049-0031
Application NumberANDA062901
Product Classification
M
Marketing Category
C73584
G
Generic Name
ampicillin sodium and sulbactam sodium
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMarch 29, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0049-0032
Application NumberANDA062901
Product Classification
M
Marketing Category
C73584
G
Generic Name
ampicillin sodium and sulbactam sodium
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMarch 29, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0049-0013
Application NumberNDA050608
Product Classification
M
Marketing Category
C73594
G
Generic Name
ampicillin sodium and sulbactam sodium
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMarch 29, 2023
FDA Product Classification
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