Amoxicillin
Rx Only To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
Approved
Approval ID
4b359b26-8682-46fa-90a1-6270502ba990
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 27, 2014
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amoxicillin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33261-726
Application NumberANDA065322
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin
Product Specifications
Route of AdministrationORAL
Effective DateMarch 28, 2014
FDA Product Classification
INGREDIENTS (7)
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
AMOXICILLINActive
Quantity: 250 mg in 5 mL
Code: 804826J2HU
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT