UNASYN
UNASYN (ampicillin sodium/sulbactam sodium)
Approved
Approval ID
12eeb72a-403d-41be-bae4-4cb930862884
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 6, 2023
Manufacturers
FDA
Roerig
DUNS: 829076996
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 Code0049-0024
Application NumberNDA050608
Product Classification
M
Marketing Category
C73594
G
Generic Name
ampicillin sodium and sulbactam sodium
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMarch 29, 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