Ampicillin and Sulbactam
AMPICILLIN AND SULBACTAM FOR INJECTION, USP
Approved
Approval ID
9a722de6-9dc0-4fb9-b63a-225385aa3314
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 23, 2023
Manufacturers
FDA
WG Critical Care, LLC
DUNS: 829274633
Products 2
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 Code44567-211
Application NumberANDA065176
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ampicillin and Sulbactam
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateFebruary 23, 2023
FDA Product Classification
INGREDIENTS (3)
SULBACTAM SODIUMActive
Quantity: 1 g in 20 mL
Code: DKQ4T82YE6
Classification: ACTIM
AMPICILLIN SODIUMActive
Quantity: 2 g in 20 mL
Code: JFN36L5S8K
Classification: ACTIM
NATURAL LATEX RUBBERInactive
Quantity: 0 1 in 20 mL
Code: 2LQ0UUW8IN
Classification: CNTM
Ampicillin and Sulbactam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code44567-210
Application NumberANDA065176
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ampicillin and Sulbactam
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateFebruary 23, 2023
FDA Product Classification
INGREDIENTS (3)
AMPICILLIN SODIUMActive
Quantity: 1 g in 10 mL
Code: JFN36L5S8K
Classification: ACTIM
SULBACTAM SODIUMActive
Quantity: 0.5 g in 10 mL
Code: DKQ4T82YE6
Classification: ACTIM
NATURAL LATEX RUBBERInactive
Quantity: 0 1 in 10 mL
Code: 2LQ0UUW8IN
Classification: CNTM