AMOXICILLIN AND CLAVULANATE POTASSIUM
Approved
Approval ID
363c6f00-67cc-44b7-b51b-14f1fddf1bb2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 18, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
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 Code16590-019
Application NumberANDA065101
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Specifications
Route of AdministrationORAL
Effective DateMay 18, 2011
FDA Product Classification
INGREDIENTS (10)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
AMOXICILLINActive
Quantity: 500 mg in 1 1
Code: 804826J2HU
Classification: ACTIB
CLAVULANATE POTASSIUMActive
Quantity: 125 mg in 1 1
Code: Q42OMW3AT8
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT