Ampicillin and Sulbactam
Ampicillin and Sulbactam for Injection, USP
Approved
Approval ID
bb78b01f-b235-4a3e-b3d2-24543d3fd56c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2015
Manufacturers
FDA
Claris Life Sciences Inc.
DUNS: 808114537
Products 2
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 Code36000-095
Application NumberANDA201406
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ampicillin sodium and sulbactam sodium
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateDecember 14, 2015
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 Code36000-094
Application NumberANDA201406
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ampicillin sodium and sulbactam sodium
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateDecember 14, 2015
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