Amoxicillin and Clavulanate Potassium
AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, 500 mg/125 mg and 875 mg/125 mg22742275Rx only
Approved
Approval ID
ee4c9c41-8ac4-4647-a765-731d8376c2d2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2011
Manufacturers
FDA
MedVantx, Inc.
DUNS: 806427725
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 Code66116-478
Application NumberANDA065096
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin and Clavulanate Potassium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 16, 2011
FDA Product Classification
INGREDIENTS (13)
CLAVULANATE POTASSIUMActive
Quantity: 125 mg in 1 1
Code: Q42OMW3AT8
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
AMOXICILLINActive
Quantity: 875 mg in 1 1
Code: 804826J2HU
Classification: ACTIM
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT