AMOXICILLIN
AMOXICILLIN powder, for suspension
Approved
Approval ID
c5774511-bee9-4ebb-a9aa-9e74de8d840e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 4, 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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-401
Application NumberANDA065334
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMOXICILLIN
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 4, 2011
FDA Product Classification
INGREDIENTS (8)
AMOXICILLINActive
Quantity: 400 mg in 5 mL
Code: 804826J2HU
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT