Amoxicillin and Clavulanate Potassium
These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
Approved
Approval ID
b04330a0-2b8d-4cf9-a08e-19007d1001ad
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 17, 2023
Manufacturers
FDA
PD-Rx Pharmaceuticals, Inc.
DUNS: 156893695
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 Code43063-077
Application NumberANDA065096
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin and Clavulanate Potassium
Product Specifications
Route of AdministrationORAL
Effective DateJuly 17, 2023
FDA Product Classification
INGREDIENTS (13)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
AMOXICILLINActive
Quantity: 875 mg in 1 1
Code: 804826J2HU
Classification: ACTIM
CLAVULANATE POTASSIUMActive
Quantity: 125 mg in 1 1
Code: Q42OMW3AT8
Classification: ACTIM
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT