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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70594-083
Application NumberANDA090578
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMPICILLIN SODIUM and SULBACTAM SODIUM
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJanuary 6, 2023
FDA Product Classification
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