Ampicillin and Sulbactam
Ampicillin and Sulbactam for Injection, USP
Approved
Approval ID
29a3c93c-3be2-441d-b59d-fd7bbc8961da
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 27, 2016
Manufacturers
FDA
West-Ward Pharmaceuticals Corp.
DUNS: 946499746
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ampicillin and Sulbactam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0641-6121
Application NumberANDA065403
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ampicillin and Sulbactam
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 28, 2016
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