Amoxicillin and Clavulanate Potassium
These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
Approved
Approval ID
fc8ddd3c-2c83-2525-e053-6294a90a101e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 26, 2023
Manufacturers
FDA
Pharmasource Meds, LLC
DUNS: 118772692
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 Code82982-069
Application NumberANDA065063
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin and Clavulanate Potassium
Product Specifications
Route of AdministrationORAL
Effective DateMay 26, 2023
FDA Product Classification
INGREDIENTS (13)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
CLAVULANATE POTASSIUMActive
Quantity: 125 mg in 1 1
Code: Q42OMW3AT8
Classification: ACTIM
AMOXICILLINActive
Quantity: 875 mg in 1 1
Code: 804826J2HU
Classification: ACTIM