Ampicillin and Sulbactam
Ampicillin and Sulbactam for Injection, USP (For Intramuscular or Intravenous Use)
Approved
Approval ID
2bfc6187-c9fc-4115-92d6-53910b5960da
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 6, 2023
Manufacturers
FDA
Xellia Pharmaceuticals USA LLC
DUNS: 116768762
Products 1
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 Code70594-083
Application NumberANDA090578
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJanuary 6, 2023
Generic NameAMPICILLIN SODIUM and SULBACTAM SODIUM
INGREDIENTS (2)
AMPICILLIN SODIUMActive
Quantity: 100 mg in 1 mL
Code: JFN36L5S8K
Classification: ACTIM
SULBACTAM SODIUMActive
Quantity: 50 mg in 1 mL
Code: DKQ4T82YE6
Classification: ACTIM