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, USP Initial U.S. Approval: 1984
Approved
Approval ID
f27ca493-48a9-9e49-e053-2a95a90ad5c2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2023
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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 Code68071-2916
Application NumberANDA201090
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin and Clavulanate Potassium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2023
FDA Product Classification
INGREDIENTS (8)
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
ORANGEInactive
Code: 5EVU04N5QU
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SUCCINIC ACIDInactive
Code: AB6MNQ6J6L
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
AMOXICILLINActive
Quantity: 400 mg in 5 mL
Code: 804826J2HU
Classification: ACTIM
CLAVULANATE POTASSIUMActive
Quantity: 57 mg in 5 mL
Code: Q42OMW3AT8
Classification: ACTIM