Augmentin
These highlights do not include all the information needed to use AUGMENTIN safely and effectively. See full prescribing information for AUGMENTIN. Augmentin (amoxicillin and clavulanate potassium) for oral suspension Initial U.S. Approval: 1984
Approved
Approval ID
f55f61af-10f1-0e17-e053-2995a90adc43
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 21, 2023
Manufacturers
FDA
Allegis Pharmaceuticals, LLC
DUNS: 792272861
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amoxicillin and Clavulanate Potassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code28595-240
Application NumberNDA050575
Product Classification
M
Marketing Category
C73594
G
Generic Name
Amoxicillin and Clavulanate Potassium
Product Specifications
Route of AdministrationORAL
Effective DateMarch 21, 2023
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SUCCINIC ACIDInactive
Code: AB6MNQ6J6L
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
CLAVULANATE POTASSIUMActive
Quantity: 31.25 mg in 5 mL
Code: Q42OMW3AT8
Classification: ACTIM
AMOXICILLINActive
Quantity: 125 mg in 5 mL
Code: 804826J2HU
Classification: ACTIM