Amoxicillin and Clavulanate Potassium
These highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium for Oral Suspension safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium for Oral Suspension. Amoxicillin and Clavulanate Potassium for Oral Suspension Initial U.S. Approval: 1984Rx Only
Approved
Approval ID
240bcdcb-31d9-40a0-87e1-bd16264a2e20
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 31, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 2
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 Code0143-9981
Application NumberANDA065191
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin and Clavulanate Potassium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2022
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
SUCCINIC ACIDInactive
Code: AB6MNQ6J6L
Classification: IACT
AMOXICILLINActive
Quantity: 200 mg in 5 mL
Code: 804826J2HU
Classification: ACTIM
CLAVULANIC ACIDActive
Quantity: 28.5 mg in 5 mL
Code: 23521W1S24
Classification: ACTIB
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
Amoxicillin and Clavulanate Potassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9982
Application NumberANDA065191
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin and Clavulanate Potassium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2022
FDA Product Classification
INGREDIENTS (7)
SUCCINIC ACIDInactive
Code: AB6MNQ6J6L
Classification: IACT
AMOXICILLINActive
Quantity: 400 mg in 5 mL
Code: 804826J2HU
Classification: ACTIM
CLAVULANIC ACIDActive
Quantity: 57 mg in 5 mL
Code: 23521W1S24
Classification: ACTIB
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT